510(k) K212516
K212516 is an FDA 510(k) premarket notification submitted by Apple, Inc. for the device "IRNF App". The FDA issued a decision of Substantially Equivalent on October 22, 2021. The device falls under product code QDB (Photoplethysmograph Analysis Software For Over-The-Counter Use), a Class II device regulated under 21 CFR 870.2790. Apple, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2021
- Date Received
- August 10, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Photoplethysmograph Analysis Software For Over-The-Counter Use
- Device Class
- Class II
- Regulation Number
- 870.2790
- Review Panel
- CV
- Submission Type
A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.