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510(k) K003442

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

K003442 is an FDA 510(k) premarket notification submitted by Electro-Diagnostic Imaging, Inc. for the device "MODIFICATION TO EDI VERIS SYSTEM". The FDA issued a decision of Substantially Equivalent on May 4, 2001. The device falls under product code HLX (Photostimulator, Ac-Powered), a Class II device regulated under 21 CFR 886.1630. Electro-Diagnostic Imaging, Inc. has at least 1 other 510(k) clearance on record.

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

  • K983983 — EDI VERIS SYSTEM (February 3, 1999)
  • K925741 — CLARUS ENDOSCOPIC HOOK KNIFE (August 24, 1993)
  • K914393 — RETINA TESTER (March 2, 1992)
  • 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)

FDA data resources