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510(k) K932571

TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 by Tomey Corporation USA — Product Code GWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1995
Date Received
May 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Photic, Evoked Response
Device Class
Class II
Regulation Number
882.1890
Review Panel
NE
Submission Type

Other clearances by Tomey Corporation USA

  • K971953 — CONFOSCAN (August 14, 1997)
  • K971685 — IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM (June 24, 1997)
  • K961805 — TOMEY DTL ELECTRODE (May 9, 1997)
  • K945959 — VIDEO VISION ANALYZER (VIVA), VRB 100 (March 1, 1995)
  • K944910 — TOMEY EM-1000 SPECULAR MICROSCOPE (November 22, 1994)
  • K924760 — TOMEY PROTON TONOMETER (April 5, 1993)
  • K921815 — TOMEY PE-300 PORTABLE ERG (July 15, 1992)
  • K912112 — PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 (June 17, 1991)

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