K893836 is an FDA 510(k) clearance for the EPLAB (ELECTROCARDIOGRAPHIC MONITOR). This device is classified as a Recorder, Magnetic Tape, Medical (Class II - Special Controls, product code DSH).
Submitted by Quinton Electrophysiology Corp. (Markham, Ontario, CA). The FDA issued a Cleared decision on September 8, 1989, 107 days after receiving the submission on May 24, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K893836 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 1989 |
| Decision Date | September 08, 1989 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DSH — Recorder, Magnetic Tape, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |