K101521 is an FDA 510(k) clearance for the ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on July 29, 2010, 57 days after receiving the submission on June 2, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K101521 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2010 |
| Decision Date | July 29, 2010 |
| Days to Decision | 57 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 |