Submission Details
| 510(k) Number | K896269 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 1989 |
| Decision Date | May 18, 1990 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
K896269 is an FDA 510(k) clearance for the SECHRIST VOLUME VENTILATOR MODEL 2200B, 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 May 18, 1990, 199 days after receiving the submission on October 31, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K896269 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 1989 |
| Decision Date | May 18, 1990 |
| Days to Decision | 199 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 |