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510(k) K111730

SONOTT FLOWLAB(R) by Em-Tec GmbH — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2012
Date Received
June 20, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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