The following data is part of a premarket notification filed by Charmcare Co., Ltd with the FDA for Charmcare Tabletop Pulse Oximeter.
| Device ID | K092641 |
| 510k Number | K092641 |
| Device Name: | CHARMCARE TABLETOP PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | CHARMCARE CO., LTD 325 N. PUENTE ST. UNIT B Brea, CA 92821 |
| Contact | Joyce Bang |
| Correspondent | Joyce Bang CHARMCARE CO., LTD 325 N. PUENTE ST. UNIT B Brea, CA 92821 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-27 |
| Decision Date | 2010-10-21 |
| Summary: | summary |