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510(k) K844736

ISIS by Oxford Medilog, Inc. — Product Code LDK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1985
Date Received
December 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sensing, Optical Contour
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

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  • K891383 — MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM (June 1, 1989)
  • K890330 — MEDILOG 6000-FD REPORT GENERATOR (April 20, 1989)

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