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510(k) K052929

PREFTEST PROFESSIONAL SUITE by Limestone Technologies, Inc. — Product Code LIL

K052929 is an FDA 510(k) premarket notification submitted by Limestone Technologies, Inc. for the device "PREFTEST PROFESSIONAL SUITE". The FDA issued a decision of Substantially Equivalent on April 26, 2006. The device falls under product code LIL (Monitor, Penile Tumescence), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2006
Date Received
October 19, 2005
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 for product code LIL

  • K061676 — RIGIDOMETER, MODEL DIR-4U (December 27, 2006)
  • K062042 — PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) (September 6, 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)
  • 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