INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
FDA 510(k) clearance K113798 · decided 2012-03-22
Clearance details
- K-number
- K113798
- Device name
- INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
- Applicant
- Draeger Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-12-23
- Decision date
- 2012-03-22
- Days to decision
- 90 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 Solution: The IACS is intended for multi-para recall (Z-1104-2021) | Draegar Medical Systems, Inc. | 2021-02-10 |
| The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M54 recall (Z-0258-2020) | Draegar Medical Systems, Inc. | 2019-10-31 |
| Draeger Infinity Acute Care System Monitoring Solution recall (Z-0714-2014) | Draeger Medical Systems, Inc. | 2014-01-10 |
| Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Inf recall (Z-0939-2013) | Draeger Medical, Inc. | 2013-03-11 |