The following data is part of a premarket notification filed by Farrall Instruments, Inc. with the FDA for Cat-400ul Penile Plethysmograph.
| Device ID | K940128 |
| 510k Number | K940128 |
| Device Name: | CAT-400UL PENILE PLETHYSMOGRAPH |
| Classification | Monitor, Penile Tumescence |
| Applicant | FARRALL INSTRUMENTS, INC. 3724 WEST ARCH AVE. Grand Island, NE 68801 |
| Contact | William R Farrall |
| Correspondent | William R Farrall FARRALL INSTRUMENTS, INC. 3724 WEST ARCH AVE. Grand Island, NE 68801 |
| 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 | 1994-01-10 |
| Decision Date | 1995-01-10 |