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510(k) K182494

FlowMet-R by Laser Associated Sciences, Inc. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2019
Date Received
September 11, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

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