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510(k) K921815

TOMEY PE-300 PORTABLE ERG by Tomey Corporation USA — Product Code HLT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1992
Date Received
April 15, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Preamplifier, Ac-Powered, Ophthalmic
Device Class
Class II
Regulation Number
886.1640
Review Panel
OP
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)
  • K932571 — TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 (August 31, 1995)
  • 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)
  • K912112 — PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 (June 17, 1991)

Other clearances for product code HLT

  • K924277 — DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING (December 7, 1994)
  • K841293 — PANORAMIC LOUPES - VARIOUS (May 9, 1984)
  • K781543 — ORBIOGRAPH (October 24, 1978)