The following data is part of a premarket notification filed by Foreo, Inc. with the FDA for Bear And Bear Mini.
| Device ID | K200803 |
| 510k Number | K200803 |
| Device Name: | BEAR And BEAR Mini |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | FOREO, Inc. 1525 E. Pama Lane Las Vegas, NV 89119 |
| Contact | Laura Hoshue |
| Correspondent | Laura Hoshue FOREO, Inc. 1525 E. Pama Lane Las Vegas, NV 89119 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-27 |
| Decision Date | 2020-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350092139526 | K200803 | 000 |
| 07350120791740 | K200803 | 000 |
| 07350120791795 | K200803 | 000 |
| 07350120791801 | K200803 | 000 |
| 07350120791818 | K200803 | 000 |
| 07350120791825 | K200803 | 000 |
| 07350120791849 | K200803 | 000 |
| 07350120790118 | K200803 | 000 |
| 07350092139502 | K200803 | 000 |
| 07350092139519 | K200803 | 000 |
| 07350120791733 | K200803 | 000 |