K080243 is an FDA 510(k) clearance for the PORTABLE OXYGEN UNIT SCA900. This device is classified as a Regulator, Pressure, Gas Cylinder (Class I - General Controls, product code CAN).
Submitted by San Cheong Co. , Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on April 7, 2009, 432 days after receiving the submission on January 31, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2700.
| 510(k) Number | K080243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2008 |
| Decision Date | April 07, 2009 |
| Days to Decision | 432 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAN — Regulator, Pressure, Gas Cylinder |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.2700 |