The following data is part of a premarket notification filed by Viatom Technology Co., Ltd. with the FDA for Checkme Pro Health Monitor.
| Device ID | K150869 |
| 510k Number | K150869 |
| Device Name: | Checkme Pro Health Monitor |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Viatom Technology Co., Ltd. C607,Languang Park, No. 7 Xinxi Road Hi-Tech Park( North) Nanshan, Shenzhen, CN 518057 |
| Contact | Zhou Saixin |
| Correspondent | Donna-bea Tillman Biologics Consulting Group, Inc. 400 N. Washington St. Suite 100 Alexandria, VA 22314 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-01 |
| Decision Date | 2015-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06934440100713 | K150869 | 000 |
| 06934440100010 | K150869 | 000 |