GSI TympStar Pro Middle Ear Analyzer— 510(k) K151509

Name: FDA 510(k) clearance K151509
Creator: U.S. Food and Drug Administration
Published: 2015-06-25

Substantially Equivalent

Diagnostic Group, Dba Grason-Stadler

FDA 510(k) clearance K151509 for GSI TympStar Pro Middle Ear Analyzer, Substantially Equivalent on 2015-06-25. Applicant: Diagnostic Group, Dba Grason-Stadler. Device class: 2.

Clearance details

Applicant: Diagnostic Group, Dba Grason-Stadler
Product code: Code ETY
Device class: Class 2
Regulation: 21 CFR 874.1090
Advisory panel: Ear, Nose, Throat
Date received: 2015-06-04
Decision date: 2015-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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K151616 — AT2352015-07-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.