K221879 is an FDA 510(k) clearance for the Patient Monitor, models LM-8, LM-10, LM-12 and LM-15. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Caf Medical Solutions, Inc. (Hockley, US). The FDA issued a Cleared decision on August 10, 2022, 43 days after receiving the submission on June 28, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K221879 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2022 |
| Decision Date | August 10, 2022 |
| Days to Decision | 43 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 |