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510(k) K003442

MODIFICATION TO EDI VERIS SYSTEM by Electro-Diagnostic Imaging, Inc. — Product Code HLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2001
Date Received
November 6, 2000
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 Electro-Diagnostic Imaging, Inc.

  • K983983 — EDI VERIS SYSTEM (February 3, 1999)

Other clearances for product code HLX

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  • K914163 — SCOPTOPIC SENSITIVITY TEST-1[SST-1] (October 25, 1991)
  • K873990 — IRAS EDS INTERFEROMETRIC STIMULATOR (February 5, 1988)
  • K853812 — PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) (November 1, 1985)
  • K833446 — DOWNING SPECTRAL ILLUMINATOR (March 12, 1984)
  • K832762 — MILLER/NADLER GLARE TESTER (September 29, 1983)
  • K831231 — LED GOGGLES (May 16, 1983)
  • K830770 — CONTRAST SENSITIVITY EQUIPMENT (April 28, 1983)