510(k) K243438
K243438 is an FDA 510(k) premarket notification submitted by Huinno Co., Ltd. for the device "MEMO Patch M (MPT-E08R-UNC01)". The FDA issued a decision of Substantially Equivalent on December 5, 2025. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2025
- Date Received
- November 6, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type