Submission Details
| 510(k) Number | K850106 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 11, 1985 |
| Decision Date | January 24, 1985 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
K850106 is an FDA 510(k) clearance for the AIRCO NITROUS OXIDE REGULATOR, a Regulator, Pressure, Gas Cylinder (Class I — General Controls, product code CAN), submitted by Airco, Inc. (Virginia Beach, US). The FDA issued a Cleared decision on January 24, 1985, 13 days after receiving the submission on January 11, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2700.
| 510(k) Number | K850106 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 11, 1985 |
| Decision Date | January 24, 1985 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAN — Regulator, Pressure, Gas Cylinder |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.2700 |