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510(k) K024205

AUDIOSCREENER OAE+ABR by Everest Biomedical Instruments Co. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2003
Date Received
December 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Audiometer
Device Class
Class II
Regulation Number
874.1050
Review Panel
EN
Submission Type

Other clearances by Everest Biomedical Instruments Co.

  • K060997 — SNAP II EEG MONITOR (June 15, 2006)

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