K203088 is an FDA 510(k) clearance for the Infinity Acute Care System (IACS) Monitoring System. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Draeger Medical Systems, Inc. (Andover, US). The FDA issued a Cleared decision on February 1, 2022, 476 days after receiving the submission on October 13, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K203088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 2020 |
| Decision Date | February 01, 2022 |
| Days to Decision | 476 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |