K082045 is an FDA 510(k) clearance for the MODIFICATION TO 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. (Las Vegas, US). The FDA issued a Cleared decision on August 1, 2008, 14 days after receiving the submission on July 18, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K082045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2008 |
| Decision Date | August 01, 2008 |
| Days to Decision | 14 days |
| Submission Type | Special |
| 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 |