The following data is part of a premarket notification filed by Shenzhen Viatom Technology Co., Ltd. with the FDA for Checkme O2 Pulse Oximeter.
| Device ID | K191088 |
| 510k Number | K191088 |
| Device Name: | Checkme O2 Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Shenzhen Viatom Technology Co., Ltd. 4E, Building 3, Tinwei Industrial Park, No.6, Liufang Rd Block 67, Xin'an Street Baoan District Guandong, CN 518101 |
| Contact | Zhou Saixin |
| Correspondent | Vaibhav Arvind Rajal mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-24 |
| Decision Date | 2019-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06934440102601 | K191088 | 000 |
| 00817698020681 | K191088 | 000 |