Hexoskin Medical System (7100-00016)— 510(k) K243981

Substantially Equivalent

Carre Technologies, Inc.

FDA 510(k) clearance K243981 for Hexoskin Medical System (7100-00016), Substantially Equivalent on 2025-11-18. Applicant: Carre Technologies, Inc..

Clearance details

Applicant: Carre Technologies, Inc.
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 2024-12-23
Decision date: 2025-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

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