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510(k) K964522

ELLIPSE 4 by Andromeda Medizinische Systeme GmbH — Product Code FEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1997
Date Received
November 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Cystometric, Hydraulic
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

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