510(k) K871690

EMED-F-SYSTEM by Novel GmbH — Product Code IKE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1987
Date Received
April 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Miniature Pressure
Device Class
Class I
Regulation Number
890.1615
Review Panel
PM
Submission Type