Hexoskin Medical System (7100-00016)— 510(k) K243981
Substantially EquivalentCarre Technologies, Inc.
FDA 510(k) clearance K243981 for Hexoskin Medical System (7100-00016), Substantially Equivalent on 2025-11-18. Applicant: Carre Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Carre Technologies, Inc.
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montreal, CA
Recent devices under product code DXH
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