K252389
- 510(k) number
- K252389
- Device name
- Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
- Applicant
- Smwmed, Inc. CA · US
- Product code
- DSH — Recorder, Magnetic Tape, Medical
- Decision date
- 2026-04-23
- Date received
- 2025-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K252389.pdf
Official FDA record: K252389
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.