FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
K Number: K252389
·
Decision Apr 23, 2026
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
1
Review Days
266
Basic Information
- Device Name
- Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
- K Number
- K252389
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smwmed, Inc.
- Date Received
- July 31, 2025
- Decision Date
- April 23, 2026
- Product Code
- DSH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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