K850794 is an FDA 510(k) clearance for the PATIENT MONITOR MODEL RM-300. This device is classified as a Heat-exchanger, Cardiopulmonary Bypass (Class II - Special Controls, product code DTR).
Submitted by Honeywell, Inc. (Pleasantville, US). The FDA issued a Cleared decision on April 18, 1985, 51 days after receiving the submission on February 26, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4240.
| 510(k) Number | K850794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1985 |
| Decision Date | April 18, 1985 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTR — Heat-exchanger, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4240 |