The following data is part of a premarket notification filed by Biobeat Technologies Ltd. with the FDA for Biobeat Platform, Bb-613wp Patch.
| Device ID | K212153 |
| 510k Number | K212153 |
| Device Name: | Biobeat Platform, BB-613WP Patch |
| Classification | Oximeter |
| Applicant | BioBeat Technologies Ltd. 26 Ha'magshimim Street Petah Tikvah, IL 4934835 |
| Contact | Johanan May |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 Thirteenth St., NW Washington, DC 20004 |
| Product Code | DQA |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DXG |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-09 |
| Decision Date | 2022-03-25 |