Device class
Class II
Regulation 870.2800
Total clearances
5
2020-08-26 → 2026-09-11
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 |
|
Zbeats, Inc. |
1 |
1 |
2026-09-11 |
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
| Date | K-number | Sponsor | Device |
|---|
| 2026-09-11 |
K261580 |
Zbeats, Inc.
|
ZBPro Diagnostic (Version 2.0) |
| 2025-03-21 |
K241890 |
Philips Medizin Systeme Böblingen GmbH
|
Philips Holter Analysis System |
| 2024-11-08 |
K240794 |
Fourth Frontier Technologies Pvt, Ltd.
|
Frontier X Plus |
| 2020-09-02 |
K200833 |
VivaQuant, Inc.
|
RX-1 Rhythm Express Remote Cardiac Monitoring System |
| 2020-08-26 |
K193177 |
Cardiocalm
|
CER-S |