K822955 is an FDA 510(k) clearance for the MODEL 4242 TELE SYST ARRHYTHMIA MONITOR. This device is classified as a Transmitters And Receivers, Electrocardiograph, Telephone (Class II - Special Controls, product code DXH).
Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on November 1, 1982, 27 days after receiving the submission on October 5, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2920.
| 510(k) Number | K822955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 1982 |
| Decision Date | November 01, 1982 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXH — Transmitters And Receivers, Electrocardiograph, Telephone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2920 |