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510(k) K831251

TUMISENSOR 1524 by Life-Tech Intl., Inc. — Product Code LIL

K831251 is an FDA 510(k) premarket notification submitted by Life-Tech Intl., Inc. for the device "TUMISENSOR 1524". The FDA issued a decision of Substantially Equivalent on June 3, 1983. The device falls under product code LIL (Monitor, Penile Tumescence), a Class U device. Life-Tech Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1983
Date Received
April 18, 1983
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 Life-Tech Intl., Inc.

  • K001129 — PROLONG, MODELS PL50, PL100, PL150 (July 6, 2000)
  • K954505 — EZ STIM (December 10, 1996)
  • K955031 — MAXISTIM (December 10, 1996)
  • K954315 — PVC ABDOMINAL/RECTAL PRESSURE CATHETER (November 30, 1995)
  • K954341 — URODYNAMICS TUBING AND INFUSION SETS (October 17, 1995)
  • K953451 — UROPUMP TUBE & DAMPING CHAMGER (October 5, 1995)
  • K953353 — UROVISION JANUS (September 8, 1995)
  • K946108 — EAR-A-GATOR (June 13, 1995)
  • K913601 — MICROPHOR (July 15, 1994)
  • K940203 — TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS (March 30, 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)
  • 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)

FDA data resources