510(k) K243981
K243981 is an FDA 510(k) premarket notification submitted by Carre Technologies, Inc. for the device "Hexoskin Medical System (7100-00016)". The FDA issued a decision of Substantially Equivalent on November 18, 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
- November 18, 2025
- Date Received
- December 23, 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