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510(k) K780540

ELECTRIC RESPONSE AUDIOMETER by Life-Tech Instruments, Inc. — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1978
Date Received
April 3, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Auditory, Evoked Response
Device Class
Class II
Regulation Number
882.1900
Review Panel
NE
Submission Type

Other clearances by Life-Tech Instruments, Inc.

  • K812177 — LIFE-TECH #1857 PRESSURE/POLOT MODULE (September 9, 1981)
  • K812179 — LIFE-TECH #1753 BIOFEEDBACK TRAINER (August 25, 1981)
  • K812180 — LIFE-TECH #5102 VISULAB (August 21, 1981)
  • K812178 — LIFE-TECH #'S 1106/1156 UROLABS (August 13, 1981)
  • K800112 — AMBLYOPIA TRAINER (March 10, 1980)
  • K790663 — MODEL 1750 STANDING URINAL (April 24, 1979)
  • K790664 — MODEL 1309 AUDIO MONITOR (April 23, 1979)
  • K781476 — MULAR GOLD LEAF ELECTRODE MODEL 7501 (November 15, 1978)
  • K781461 — MODEL 7320 VISUAL STIMULATOR (November 8, 1978)
  • K781474 — PREAMPLIFIER MODELS 8101PI & 8102PI (September 7, 1978)

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