K914607 is an FDA 510(k) clearance for the SEHRIST VOLUME VENTILATOR, MODEL 2200B. This device is classified as a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK).
Submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on November 2, 1992, 382 days after receiving the submission on October 17, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K914607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 1991 |
| Decision Date | November 02, 1992 |
| Days to Decision | 382 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBK — Ventilator, Continuous, Facility Use |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5895 |