The following data is part of a premarket notification filed by Chronisense Medical, Ltd. with the FDA for Polso Watch.
| Device ID | K220351 |
| 510k Number | K220351 |
| Device Name: | Polso Watch |
| Classification | Oximeter |
| Applicant | Chronisense Medical, Ltd. 2 Hacarmel St. P.O.B. 399 Yokneam Illit, IL 2066724 |
| Contact | Bridget Ross |
| Correspondent | Allison Komiyama RQM+ 2251 San Diego Ave. Ste B-257 San Diego, CA 92110 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-07 |
| Decision Date | 2022-11-18 |