9055 Irca Option for System Athena 9050 NT
FDA 510(k) K930134 · S & W Medico Teknik
510(k) numberK930134
Submission
- Device name
- 9055 Irca Option for System Athena 9050 NT
- Applicant
- S & W Medico Teknik
Denmark, DK - Received
- January 12, 1993
- Decision date
- April 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
More from Masimo Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K940933 | 9267 SPO2 Athena ModuleDQA · Traditional | 11/29/1995SE |
| K913013 | TCPO2 9260 Module - System AthenaLKD · Traditional | 05/03/1994SE |
| K915633 | Mod. Type 9230 Temp 1 and Temp 2 System AthenaFLL · Traditional | 06/29/1993SE |
| K923418 | 9293/1 Interface ModuleDQA · Traditional | 02/23/1993SE |
| K911611 | System Athena, ModificationDRT · Traditional | 02/05/1993SE |
| K922314 | Ventilator Interface 9291/4CBK · Traditional | 12/17/1992SE |
| K912815 | Nibp 9225 CombiDXN · Traditional | 10/09/1992SE |
| K912000 | Type Interface 9271/1 Incubator/WarmerFMZ · Traditional | 09/21/1992SE |
| K912183 | Type 9050/NEODPS · Traditional | 06/23/1992SE |
| K912145 | System Athena-Product Enhancements, AnesthesiaCCE · Traditional | 05/05/1992SE |
Questions and answers
When was 9055 Irca Option for System Athena 9050 NT cleared by the FDA?
9055 Irca Option for System Athena 9050 NT (K930134) received a 510(k) decision of Substantially Equivalent on April 9, 1993, 87 days after the submission was received.
What is the product code of K930134?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.