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510(k) K810699

PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM by Visidyne Corp. — Product Code HLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1981
Date Received
March 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photostimulator, Ac-Powered
Device Class
Class II
Regulation Number
886.1630
Review Panel
OP
Submission Type

Other clearances by Visidyne Corp.

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  • K810700 — CHROMOPS FM-100 COLOR VISION TESTER (April 10, 1981)

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  • K833446 — DOWNING SPECTRAL ILLUMINATOR (March 12, 1984)
  • K832762 — MILLER/NADLER GLARE TESTER (September 29, 1983)
  • K831231 — LED GOGGLES (May 16, 1983)