The following data is part of a premarket notification filed by Farrall Instruments, Inc. with the FDA for Cat-600 Penile Plethysmograph.
Device ID | K936115 |
510k Number | K936115 |
Device Name: | CAT-600 PENILE PLETHYSMOGRAPH |
Classification | Monitor, Penile Tumescence |
Applicant | FARRALL INSTRUMENTS, INC. 3724 ARCH AVE. Grand Island, NE 68803 |
Contact | William R Farrall |
Correspondent | William R Farrall FARRALL INSTRUMENTS, INC. 3724 ARCH AVE. Grand Island, NE 68803 |
Product Code | LIL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-19 |
Decision Date | 1995-01-10 |