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510(k) K940128

CAT-400UL PENILE PLETHYSMOGRAPH by Farrall Instruments, Inc. — Product Code LIL

K940128 is an FDA 510(k) premarket notification submitted by Farrall Instruments, Inc. for the device "CAT-400UL PENILE PLETHYSMOGRAPH". The FDA issued a decision of Substantially Equivalent on January 10, 1995. The device falls under product code LIL (Monitor, Penile Tumescence), a Class U device. Farrall Instruments, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1995
Date Received
January 10, 1994
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

Other clearances by Farrall Instruments, Inc.

  • K936115 — CAT-600 PENILE PLETHYSMOGRAPH (January 10, 1995)
  • K821723 — BI-4520 DUAL IMPEDOMETER (September 15, 1982)
  • K821664 — PP-100, PERSONAL PERINEOMETER (July 13, 1982)
  • K792305 — A SLEEP ASSESSMENT DEVICE (December 20, 1979)
  • K781634 — VISUALAX (October 3, 1978)
  • K760166 — STIMULATOR, SONIC CONTROL (AS-1) (July 20, 1976)

Other clearances for product code LIL

  • K061676 — RIGIDOMETER, MODEL DIR-4U (December 27, 2006)
  • K062042 — PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) (September 6, 2006)
  • K052929 — PREFTEST PROFESSIONAL SUITE (April 26, 2006)
  • K033126 — MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM (October 29, 2003)
  • K000194 — DIGITAL INFLECTION RIGIDOMETER (DIR) (April 10, 2000)
  • K991479 — VISER PENILE TUMESCENCE MONITOR (July 7, 1999)
  • K980627 — NEVA SYSTEM (April 7, 1998)
  • K936115 — CAT-600 PENILE PLETHYSMOGRAPH (January 10, 1995)
  • K941781 — RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM (August 25, 1994)
  • K925931 — RT2 RIGIDITY AND TUMESCENCE TEST (December 21, 1992)

FDA data resources