510(k) K960840

C.E. VASCULAR MACHINE by C.E. Diagnosis, Inc. — Product Code JEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1997
Date Received
February 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Volume
Device Class
Class II
Regulation Number
868.1760
Review Panel
AN
Submission Type