Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
Device Facts
| Record ID | K252389 |
|---|---|
| Device Name | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) |
| Applicant | Smwmed, Inc. |
| Product Code | DSH · Cardiovascular |
| Decision Date | Apr 23, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2800 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.
