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510(k) K980533

ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) by Etymotic Research — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1998
Date Received
February 11, 1998
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

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  • K873298 — ELEC-TIP (November 24, 1987)
  • K861113 — ER-7C CLINICAL PROBE MICROPHONE (April 23, 1986)
  • K843144 — K-BASS LO FREQUENCY HEARING AID (September 7, 1984)

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