K243438
- 510(k) number
- K243438
- Device name
- MEMO Patch M (MPT-E08R-UNC01)
- Applicant
- Huinno Co., Ltd. KR
- Product code
- DXH — Transmitters And Receivers, Electrocardiograph, Tele
- Decision date
- 2025-12-05
- Date received
- 2024-11-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.7 MB · U.S. public domain
Also available from FDA: K243438.pdf
Official FDA record: K243438
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.