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510(k) K790637

COMPUTERIZED ELECTRO-OCULOGRAPH by Potomac Medical System — Product Code HLX

K790637 is an FDA 510(k) premarket notification submitted by Potomac Medical System for the device "COMPUTERIZED ELECTRO-OCULOGRAPH". The FDA issued a decision of Substantially Equivalent on August 28, 1979. The device falls under product code HLX (Photostimulator, Ac-Powered), a Class II device regulated under 21 CFR 886.1630. Potomac Medical System has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1979
Date Received
April 2, 1979
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 Potomac Medical System

  • K851174 — METACHROME (May 23, 1985)

Other clearances for product code HLX

  • K003442 — MODIFICATION TO EDI VERIS SYSTEM (May 4, 2001)
  • 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)

FDA data resources