510(k) K951129

NOVATRANS II by Medex, Inc. — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1995
Date Received
March 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type