Device class
Class II
Regulation 870.2800
Total clearances
4
2020-08-26 → 2025-03-21
Classification details
Medical specialty
Cardiovascular
Regulation number
870.2800
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
VivaQuant, Inc. |
1 |
0 |
2020-09-02 |
|
Cardiocalm |
1 |
0 |
2020-08-26 |
|
Philips Medizin Systeme Böblingen GmbH
|
1 |
0 |
2025-03-21 |
|
Fourth Frontier Technologies Pvt, Ltd. |
1 |
0 |
2024-11-08 |
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
|
Electrocardiogram, complete; includes automated analysis of waveform |
| 93005 |
CPT
|
— |
High
|
Electrocardiogram, ambulatory recording and analysis |
Pulse
Most recent 510(k) clearances