510(k) K880903

BARD (R) ESKA ERECTIOMETER by C.R. Bard, Inc. — Product Code LIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1988
Date Received
March 2, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Penile Tumescence
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type