Infinity CentralStation Wide
FDA 510(k) clearance K151860 · decided 2015-09-02
Clearance details
- K-number
- K151860
- Device name
- Infinity CentralStation Wide
- Applicant
- Draeger Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-07-08
- Decision date
- 2015-09-02
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is inten recall (Z-1066-2025) | Draeger Medical Systems, Inc. | 2025-01-30 |
| Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neon recall (Z-1471-2023) | Draeger Medical Systems, Inc. | 2023-04-27 |