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510(k) K781543

ORBIOGRAPH by Sonometrics Systems, Inc. — Product Code HLT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1978
Date Received
September 8, 1978
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 Sonometrics Systems, Inc.

  • K820751 — GLAUKON (April 9, 1982)
  • K812015 — GLAUKON (February 8, 1982)
  • K802341 — DIOSCAN (December 10, 1980)

Other clearances for product code HLT

  • K924277 — DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING (December 7, 1994)
  • K921815 — TOMEY PE-300 PORTABLE ERG (July 15, 1992)
  • K841293 — PANORAMIC LOUPES - VARIOUS (May 9, 1984)