CAT-600 PENILE PLETHYSMOGRAPH

Monitor, Penile Tumescence

FARRALL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Farrall Instruments, Inc. with the FDA for Cat-600 Penile Plethysmograph.

Pre-market Notification Details

Device IDK936115
510k NumberK936115
Device Name:CAT-600 PENILE PLETHYSMOGRAPH
ClassificationMonitor, Penile Tumescence
Applicant FARRALL INSTRUMENTS, INC. 3724 ARCH AVE. Grand Island,  NE  68803
ContactWilliam R Farrall
CorrespondentWilliam R Farrall
FARRALL INSTRUMENTS, INC. 3724 ARCH AVE. Grand Island,  NE  68803
Product CodeLIL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-19
Decision Date1995-01-10

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