K062095 is an FDA 510(k) clearance for the MCARE 300 VITAL SIGNS MONITOR, MODEL 91220. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Spacelabs Medical, Inc. (Issaquah, US). The FDA issued a Cleared decision on September 29, 2006, 67 days after receiving the submission on July 24, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K062095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2006 |
| Decision Date | September 29, 2006 |
| Days to Decision | 67 days |
| Submission Type | Abbreviated |
| 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 |