K821959 is an FDA 510(k) clearance for the CARDIO-RESPIRATORY MONITOR MODEL CR-1. This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II - Special Controls, product code DRT).
Submitted by Electromed Intl., Ltd. (Walker, US). The FDA issued a Cleared decision on July 20, 1982, 20 days after receiving the submission on June 30, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K821959 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1982 |
| Decision Date | July 20, 1982 |
| Days to Decision | 20 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 |