K241583

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)

510(k) number
K241583
Device name
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. GA · US
Product code
DPW — Flowmeter, Blood, Cardiovascular
Decision date
2024-08-30
Date received
2024-06-03
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K241583.pdf

Official FDA record: K241583
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.