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510(k) K033126

MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM by Behavioral Technology, Inc. — Product Code LIL

K033126 is an FDA 510(k) premarket notification submitted by Behavioral Technology, Inc. for the device "MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM". The FDA issued a decision of Substantially Equivalent on October 29, 2003. The device falls under product code LIL (Monitor, Penile Tumescence), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2003
Date Received
September 30, 2003
Clearance Type
Special
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 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)
  • 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)
  • K940128 — CAT-400UL 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