The following data is part of a premarket notification filed by Wesper Inc. with the FDA for Wespero2.
| Device ID | K213515 |
| 510k Number | K213515 |
| Device Name: | WesperO2 |
| Classification | Oximeter |
| Applicant | Wesper Inc. 234 5th Ave New York, NY 10001 |
| Contact | Amir Reuveny |
| Correspondent | Amir Reuveny Wesper Inc. 234 5th Ave New York, NY 10001 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-02 |
| Decision Date | 2022-06-10 |