K014261 is an FDA 510(k) clearance for the ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0. 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, Inc. (Andover, US). The FDA issued a Cleared decision on February 12, 2002, 47 days after receiving the submission on December 27, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K014261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2001 |
| Decision Date | February 12, 2002 |
| Days to Decision | 47 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 |