K862647 is an FDA 510(k) clearance for the PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403. This device is classified as a Computer, Blood-pressure (Class II - Special Controls, product code DSK).
Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on August 18, 1986, 38 days after receiving the submission on July 11, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1110.
| 510(k) Number | K862647 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 1986 |
| Decision Date | August 18, 1986 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DSK — Computer, Blood-pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1110 |