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510(k) K833883

DIGITAL AUDIOMETER/HEARING AID 3100 by Frye Electronics, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1984
Date Received
November 9, 1983
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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  • K872242 — TYPE 6400 REAL EAR HEARING AID ANALYZER (July 10, 1987)
  • K861571 — TYPE 6500 HEARING AID ANALYZER (May 30, 1986)
  • K850918 — TYPE FP30 DIGITAL HEARING AID ANALYZER (May 29, 1985)

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