K241583

Substantially Equivalent

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)

Applicant: Remington Medical, Inc.
Product code: DPW
Advisory panel: Cardiovascular
Date received: 2024-06-03
Decision date: 2024-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Alpharetta, GA, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.