NICOLET REAL EAR ANALYZER— 510(k) K896477

Name: FDA 510(k) clearance K896477
Creator: U.S. Food and Drug Administration
Published: 1990-02-08

Substantially Equivalent

Nicolet Instrument Corp.

FDA 510(k) clearance K896477 for NICOLET REAL EAR ANALYZER, Substantially Equivalent on 1990-02-08. Applicant: Nicolet Instrument Corp.. Device class: 2.

Clearance details

Applicant: Nicolet Instrument Corp.
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 1989-11-13
Decision date: 1990-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

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