510(k) K040909

SONO TT ULTRASONIC FLOWCOMPUTER by Em-Tec GmbH — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2004
Date Received
April 8, 2004
Clearance Type
Traditional
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