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510(k) K961642

MEDILOG MR95 by Oxford Instruments, Plc. — Product Code GWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1997
Date Received
April 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full-Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

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  • K933816 — SONICAID MODEL P110 FETAL HEAR DETECTOR (December 22, 1994)

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