Device class
Class II
Regulation 870.2345
Total clearances
8
2020-08-04 → 2025-06-15
Definition
What is Electrocardiograph Software For Over-The-Counter Use
An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.
Classification details
Medical specialty
Cardiovascular
Regulation number
870.2345
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 |
| 93000 |
CPT
|
— |
High
|
Electrocardiography (ECG); OTC software analyzes ECG data for arrhythmias |
| 93040 |
CPT
|
— |
Medium
|
ECG interpretation; rhythm analysis software |
Pulse
Most recent 510(k) clearances