The following data is part of a premarket notification filed by Bio-beat Technologies Ltd. with the FDA for Bb-613 Watch Oximeter.
| Device ID | K181006 |
| 510k Number | K181006 |
| Device Name: | BB-613 Watch Oximeter |
| Classification | Oximeter |
| Applicant | Bio-Beat Technologies Ltd. 26 Magshimim Street Petach Tikvah, IL 4934835 |
| Contact | Johanan May |
| Correspondent | Yarmela Pavlovic Hogan Lovells US LLP 3 Embarcadero Center Suite 1500 San Francisco, CA 94111 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-16 |
| Decision Date | 2018-09-21 |
| Summary: | summary |