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510(k) K021215

BIO-LOGIC ABAER CUB by Bio-Logic Systems Corp. — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2002
Date Received
April 17, 2002
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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  • K031009 — MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM (April 28, 2003)
  • K021895 — BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM (July 1, 2002)
  • K021801 — BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS (June 27, 2002)

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