VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)— 510(k) K251904

Substantially Equivalent

Remington Medical, Inc.

FDA 510(k) clearance K251904 for VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01), Substantially Equivalent on 2025-11-20. Applicant: Remington Medical, Inc..

Clearance details

Applicant: Remington Medical, Inc.
Product code: Code DPW
Advisory panel: Cardiovascular
Date received: 2025-06-20
Decision date: 2025-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

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