K853501 is an FDA 510(k) clearance for the HONEYWELL ELECTRONIC VENTILATOR EV-A. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Honeywell, Inc. (Pleasantville, US). The FDA issued a Cleared decision on April 4, 1986, 227 days after receiving the submission on August 20, 1985.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K853501 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1985 |
| Decision Date | April 04, 1986 |
| Days to Decision | 227 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 |