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510(k) K912139

MODEL 704 by Ivy Biomedical Systems, Inc. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1992
Date Received
May 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

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