K770038 is an FDA 510(k) clearance for the MONITOR, HEARTWATCH HEART RATE. This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II - Special Controls, product code DRT).
Submitted by Respironics, Inc. (Monroeville, US). The FDA issued a Cleared decision on January 14, 1977, 4 days after receiving the submission on January 10, 1977.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K770038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1977 |
| Decision Date | January 14, 1977 |
| Days to Decision | 4 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRT — Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |