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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name flowmeter, blood, cardiovascular
510(k) Number K211589
Device Name VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
Applicant
Remington Medical, Inc.
6830 Meadowridge Court
Alpharetta,  GA  30005
Applicant Contact Caitlin Senter
Correspondent
Remington Medical, Inc.
6830 Meadowridge Court
Alpharetta,  GA  30005
Correspondent Contact Matt Brown
Regulation Number870.2100
Classification Product Code
DPW  
Date Received05/24/2021
Decision Date 01/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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