K860545 is an FDA 510(k) clearance for the VAPORIZER SPACER. 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 April 17, 1986, 63 days after receiving the submission on February 13, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5880.
| 510(k) Number | K860545 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1986 |
| Decision Date | April 17, 1986 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAD — Vaporizer, Anesthesia, Non-heated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5880 |