K863318 is an FDA 510(k) clearance for the AEROSOL-T. This device is classified as a Connector, Airway (extension) (Class I - General Controls, product code BZA).
Submitted by Southmedic, Inc. (Barrie, Ontario Canada, CA). The FDA issued a Cleared decision on September 11, 1986, 16 days after receiving the submission on August 26, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5810.
| 510(k) Number | K863318 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 1986 |
| Decision Date | September 11, 1986 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZA — Connector, Airway (extension) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5810 |