The following data is part of a premarket notification filed by Apple Inc. with the FDA for Irnf App.
| Device ID | K212516 |
| 510k Number | K212516 |
| Device Name: | IRNF App |
| Classification | Photoplethysmograph Analysis Software For Over-the-counter Use |
| Applicant | Apple Inc. 1 Apple Park Way Cupertino, CA 95014 |
| Contact | Dachan Kwon |
| Correspondent | Luke Olson Apple Inc. 1 Apple Park Way Cupertino, CA 95014 |
| Product Code | QDB |
| CFR Regulation Number | 870.2790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-10 |
| Decision Date | 2021-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00194252456781 | K212516 | 000 |
| 00194252456774 | K212516 | 000 |