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510(k) K923072

HANDTYMP by Life-Tech Intl., Inc. — Product Code ETY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1993
Date Received
June 25, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Auditory Impedance
Device Class
Class II
Regulation Number
874.1090
Review Panel
EN
Submission Type

Other clearances by Life-Tech Intl., Inc.

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  • 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 ETY

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  • K161707 — Madsen Zodiac (September 1, 2016)
  • K151616 — AT235 (July 15, 2015)
  • K151509 — GSI TympStar Pro Middle Ear Analyzer (June 25, 2015)
  • K133013 — INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE P (January 24, 2014)
  • K121847 — TITAN (November 29, 2012)
  • K083861 — TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MOD (April 9, 2009)
  • K081841 — AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER (July 16, 2008)