K894316 is an FDA 510(k) clearance for the AMADEUS VENTILATOR. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Hamilton Medical, Inc. (Reno, US). The FDA issued a Cleared decision on September 22, 1989, 70 days after receiving the submission on July 14, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K894316 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1989 |
| Decision Date | September 22, 1989 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CBK — Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |