BRENTWOOD PC-ECG
FDA 510(k) clearance K955023 · decided 1997-01-22
Clearance details
- K-number
- K955023
- Device name
- BRENTWOOD PC-ECG
- Applicant
- Brentwood Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-02
- Decision date
- 1997-01-22
- Days to decision
- 447 days
- Clearance type
- Traditional
- Product code
- DSI
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Torrance, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IQecg IQiC Interface, Part Numbers: 4-100-1407, Software Version 6.0 IQecg is to be used, recall (Z-2724-2011) | Brentwood Medical Technology Corp | 2011-07-14 |
| IQecg IQdevices SDK, Part Numbers: 4-100-1403, Software Version 8.3.2 Product Usage: IQecg recall (Z-2725-2011) | Brentwood Medical Technology Corp | 2011-07-14 |
| IQecg IQmanager Diagnostic Workstation, Part Numbers: 4-100-1200, Software Version 8.0.1, recall (Z-2726-2011) | Brentwood Medical Technology Corp | 2011-07-14 |