K802644 is an FDA 510(k) clearance for the EMERG. OXYGEN KIT #65350 & #65399 CASE. This device is classified as a Regulator, Pressure, Gas Cylinder (Class I - General Controls, product code CAN).
Submitted by B & F Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980, 59 days after receiving the submission on October 24, 1980.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2700.
| 510(k) Number | K802644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 1980 |
| Decision Date | December 22, 1980 |
| Days to Decision | 59 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 |