The following data is part of a premarket notification filed by Biobeat Technologies Ltd. with the FDA for Bb-613wp.
| Device ID | K190792 |
| 510k Number | K190792 |
| Device Name: | BB-613WP |
| Classification | Oximeter |
| Applicant | BioBeat Technologies Ltd. 26 Ha’magshimim Street Petah Tikvah, IL 4934835 |
| Contact | Johanan May |
| Correspondent | Yarmela Pavlovic Hogan Lovells US LPP 3 Embarcadero Center, Suite 1500 San Francisco, CA 94111 |
| Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DXN |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-27 |
| Decision Date | 2019-08-22 |