510(k) K231173
- Device
- Irregular Rhythm Notification Feature (IRNF)
- Applicant
- Apple, Inc.
- 510(k) number
- K231173
- Product code
- QDB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-07-21
- Date received
- 2023-04-25
- Regulation
- 870.2790
- Classification name
- Photoplethysmograph Analysis Software For Over-The-Counter Use
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Bonnie Wu
- Address
- One Apple Park Way Cupertino CA US 95014 95014
FDA Registration Numbers
- 3014343954
- 3009253624
- 3017616353