Photoplethysmograph Analysis Software For Over-The-Counter Use
The Photoplethysmograph Analysis Software For Over-The-Counter Use is a software device that analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms in an over-the-counter consumer setting; it is not intended to provide a diagnosis. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is QDB under regulation 870.2790 in the Cardiovascular specialty. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- QDB
- Device Class
- FDA class 2
- Regulation Number
- 870.2790
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231173 | Irregular Rhythm Notification Feature (IRNF) | Jul 21, 2023 | Substantially Equivalent | Apple, Inc. |
| K213971 | Atrial Fibrillation History Feature | Jun 03, 2022 | Substantially Equivalent | Apple, Inc. |
| K212372 | Fitbit Irregular Rhythm Notifications | Apr 08, 2022 | Substantially Equivalent | Fitbit, Inc. |
| K212516 | IRNF App | Oct 22, 2021 | Substantially Equivalent | Apple, Inc. |
| DEN180042 | Irregular Rhythm Notification Feature | Sep 11, 2018 | Unknown | Apple, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.