Infinity Acute Care System (IACS) Monitoring System
FDA 510(k) clearance K203088 · decided 2022-02-01
Clearance details
- K-number
- K203088
- Device name
- Infinity Acute Care System (IACS) Monitoring System
- Applicant
- Draeger Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-10-13
- Decision date
- 2022-02-01
- Days to decision
- 476 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 Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. M recall (Z-2189-2024) | Draeger Medical Systems, Inc. | 2024-06-25 |