K801515 is an FDA 510(k) clearance for the ABBY II PATIENT MONITOR OR VITAL SIGNS M. This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II - Special Controls, product code DRT).
Submitted by Abbott Medical Electronics Co. (Fort Worth, US). The FDA issued a Cleared decision on July 8, 1980, 8 days after receiving the submission on June 30, 1980.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K801515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1980 |
| Decision Date | July 08, 1980 |
| Days to Decision | 8 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 |