Bci Advisor Vital Signs Monitor (9200)
FDA 510(k) K011177 · Bci, Inc.
510(k) numberK011177
Submission
- Device name
- Bci Advisor Vital Signs Monitor (9200)
- Applicant
- Bci, Inc.
Waukesha, WI, US - Received
- April 17, 2001
- Decision date
- May 23, 2001
- 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 |
|---|---|---|
| K030407 | Advisor, Model 9200CCK · Traditional | 08/19/2003SE |
| K031742 | Bci 6004 Nibp Monitor with Nellcor Pulse OximeterDQA · Traditional | 08/18/2003SE |
| K020739 | Bci 3178 Pediatric Pulse Oximetry SensorDQA · Traditional | 06/03/2002SE |
| K020350 | Bci 3180 Pulse OximeterDQA · Traditional | 04/30/2002SE |
| K013862 | Bci 1621 Oximetry Data Management ProgramDQA · Traditional | 02/21/2002SE |
| K013171 | 3420 Digit Pulse Oximeter, Model 3420DQA · Traditional | 01/03/2002SE |
| K011156 | Bci 3403 Sleep Screening Pulse OximeterDQA · Traditional | 06/14/2001SE |
| K010770 | Bci Advisor Vital Signs Monitor (9200)MWI · Traditional | 06/12/2001SE |
| K001770 | Bci M4529A Oem Digital Handheld Oximeter, Model M4529ADQA · Special | 07/05/2000SE |
| K944121 | Sharps Container 18 GallonFMI · Traditional | 01/27/1995SE |
Questions and answers
When was Bci Advisor Vital Signs Monitor (9200) cleared by the FDA?
Bci Advisor Vital Signs Monitor (9200) (K011177) received a 510(k) decision of Substantially Equivalent on May 23, 2001, 36 days after the submission was received.
What is the product code of K011177?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.