Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel Version, 2001268 40 Channel Versio
FDA 510(k) K050006 · C.R. Bard, Inc.
510(k) numberK050006
Submission
- Device name
- Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel Version, 2001268 40 Channel Versio
- Applicant
- C.R. Bard, Inc.
Lowell, MA, US - Received
- January 3, 2005
- Decision date
- May 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRQ – Amplifier And Signal Conditioner, Transducer Signal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2060
- Specialty
- Cardiovascular
Other 510(k)s with product code DRQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172216 | ACIST RXi Mini SystemDRQ · Special | Acist Medical Systems, Inc. | 08/18/2017SE |
| K152693 | CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II…DRQ · Special | Boston Scientific Corporation | 10/21/2015SE |
| K150235 | CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II…DRQ · Special | Boston Scientific Corporation | 04/22/2015SE |
| K050974 | Draeger Medical Information Bus (Mib, Mib II, Mib Duo) Protocol ConvertersDRQ · Special | Draeger Medical Systems, Inc. | 04/29/2005SE |
| K033807 | Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol ConverterDRQ · Special | Draeger Medical Systems, Inc. | 03/09/2004SE |
| K013205 | Millar Pressure Control Unit Model PCU-2000DRQ · Traditional | Millar Instruments, Inc. | 07/02/2002SE |
| K020277 | Siemens Medical Infromation Bus (Mib II) Protocol ConverterDRQ · Special | Siemens Medical Solutions USA, Inc. | 02/19/2002SE |
| K010640 | Siemens Medical Information Bus (Mib II) Protocol ConverterDRQ · Special | Siemens Medical Solutions USA, Inc. | 03/20/2001SE |
| K913875 | Bard(R) Biopotential Amplifier IIDRQ · Traditional | Bard Electrophysiology | 11/27/1991SE |
| K913110 | PDM-1 Device:Capd Disinfecting Device, ModifiedDRQ · Traditional | Microwave Medical Systems, Inc. | 10/10/1991SE |
More from Microwave Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | 07/10/2026SE |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | 05/29/2026SESK |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | 03/17/2026SE |
| K251864 | Rubber Utility CatheterKOD · Traditional | 02/23/2026SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
| K222793 | WavelinQ GeneratorGEI · Special | 10/17/2022SE |
| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | 06/21/2022SE |
Questions and answers
When was Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel Version, 2001268 40 Channel Versio cleared by the FDA?
Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel Version, 2001268 40 Channel Versio (K050006) received a 510(k) decision of Substantially Equivalent on May 27, 2005, 144 days after the submission was received.
What is the product code of K050006?
The FDA product code is DRQ – Amplifier And Signal Conditioner, Transducer Signal, a Class II (moderate risk) device regulated under 21 CFR 870.2060.