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510(k) K073626

BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM by Bio-Logic Systems Corp. — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2008
Date Received
December 26, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Auditory, Evoked Response
Device Class
Class II
Regulation Number
882.1900
Review Panel
NE
Submission Type

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  • K021801 — BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS (June 27, 2002)
  • K021215 — BIO-LOGIC ABAER CUB (May 15, 2002)

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