510(k) K770115

ARTERIAL DIAGNOSTIC UNIT (ADU) by Medical Electronic Devices, Inc. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1977
Date Received
January 19, 1977
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