K945993 is an FDA 510(k) clearance for the VAPOFIL. This device is classified as a Vaporizer, Anesthesia, Non-heated (Class II - Special Controls, product code CAD).
Submitted by Southmedic, Inc. (Barrie, Ontario Canada, CA). The FDA issued a Cleared decision on February 22, 1995, 96 days after receiving the submission on November 18, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5880.
| 510(k) Number | K945993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1994 |
| Decision Date | February 22, 1995 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAD - Vaporizer, Anesthesia, Non-heated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5880 |