The following data is part of a premarket notification filed by San Cheong Co. Ltd. with the FDA for Portable Oxygen Unit Sca900.
| Device ID | K080243 |
| 510k Number | K080243 |
| Device Name: | PORTABLE OXYGEN UNIT SCA900 |
| Classification | Regulator, Pressure, Gas Cylinder |
| Applicant | SAN CHEONG CO. LTD. 13340 E FIRESTONE BLVD SUITE J Santa Fe Springs, CA 90670 |
| Contact | Jung Bae Bang |
| Correspondent | Jung Bae Bang SAN CHEONG CO. LTD. 13340 E FIRESTONE BLVD SUITE J Santa Fe Springs, CA 90670 |
| Product Code | CAN |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-31 |
| Decision Date | 2009-04-07 |
| Summary: | summary |