Device class
Class II
Regulation 870.2790
Total clearances
4
2021-10-22 → 2023-07-21
Definition
What is Photoplethysmograph Analysis Software For Over-The-Counter Use
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.
Classification details
Medical specialty
Cardiovascular
Regulation number
870.2790
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 93040 |
CPT
|
— |
Medium
|
ECG rhythm interpretation; photoplethysmography analysis for arrhythmia detection |
| 94060 |
CPT
|
— |
Medium
|
Pulse oximetry; related to photoplethysmographic measurement |
Pulse
Most recent 510(k) clearances