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510(k) K000194

DIGITAL INFLECTION RIGIDOMETER (DIR) by Uroan Xxi Electromedicina — Product Code LIL

K000194 is an FDA 510(k) premarket notification submitted by Uroan Xxi Electromedicina for the device "DIGITAL INFLECTION RIGIDOMETER (DIR)". The FDA issued a decision of Substantially Equivalent on April 10, 2000. The device falls under product code LIL (Monitor, Penile Tumescence), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2000
Date Received
January 21, 2000
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)
  • K052929 — PREFTEST PROFESSIONAL SUITE (April 26, 2006)
  • K033126 — MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM (October 29, 2003)
  • K991479 — VISER PENILE TUMESCENCE MONITOR (July 7, 1999)
  • K980627 — NEVA SYSTEM (April 7, 1998)
  • K940128 — CAT-400UL PENILE PLETHYSMOGRAPH (January 10, 1995)
  • 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