SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
FDA 510(k) clearance K152881 · decided 2016-04-01
Clearance details
- K-number
- K152881
- Device name
- SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
- Applicant
- Spacelabs Healthcare, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-09-30
- Decision date
- 2016-04-01
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hertford, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software V recall (Z-0416-2026) | Spacelabs Healthcare, Ltd. | 2025-10-31 |