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510(k) K970555

IL0292 DP ECHOPORT by Smith — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1997
Date Received
February 13, 1997
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 Smith

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  • K972123 — PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 (July 25, 1997)
  • K971092 — QA-ES (April 23, 1997)

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