VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger

Flowmeter, Blood, Cardiovascular

Remington Medical, Inc.

The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Vascuchek Kit, Vascuchek Transceiver, Vascuchek Clinical Probe, Vascuchek Charger.

Pre-market Notification Details

Device IDK212065
510k NumberK212065
Device Name:VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger
ClassificationFlowmeter, Blood, Cardiovascular
Applicant Remington Medical, Inc. 6830 Meadowridge Court Alpharetta,  GA  30005
ContactCaitlin Senter
CorrespondentC. Matt Brown
Remington Medical, Inc. 6830 Meadowridge Court Alpharetta,  GA  30005
Product CodeDPW  
CFR Regulation Number870.2100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-02
Decision Date2021-10-07

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