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510(k) K944910

TOMEY EM-1000 SPECULAR MICROSCOPE by Tomey Corporation USA — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1994
Date Received
October 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

Other clearances by Tomey Corporation USA

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  • 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)
  • 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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