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510(k) K991479

VISER PENILE TUMESCENCE MONITOR by Laborie Medical Tech Corp. — Product Code LIL

K991479 is an FDA 510(k) premarket notification submitted by Laborie Medical Tech Corp. for the device "VISER PENILE TUMESCENCE MONITOR". The FDA issued a decision of Substantially Equivalent on July 7, 1999. The device falls under product code LIL (Monitor, Penile Tumescence), a Class U device. Laborie Medical Tech Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1999
Date Received
April 28, 1999
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 Laborie Medical Tech Corp.

  • K993721 — UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES (November 29, 1999)
  • K990041 — UROSTYM BIOFEEDBACK AND STIMULATION PROBES (August 5, 1999)
  • K963064 — ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM (June 5, 1997)
  • K950016 — CART, MODE NUMBER UDS-CART (March 30, 1995)
  • K941105 — UORCAP,MODEL NUMBER UDS-UCAP (May 10, 1994)

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)
  • 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