Sienna Ultimate Wireless Amplifier— 510(k) K171397

Name: FDA 510(k) clearance K171397
Creator: U.S. Food and Drug Administration
Published: 2017-10-06

Substantially Equivalent

Ems Handels Gesellschaft M.B.H.

FDA 510(k) clearance K171397 for Sienna Ultimate Wireless Amplifier, Substantially Equivalent on 2017-10-06. Applicant: Ems Handels Gesellschaft M.B.H.. Device class: 2.

Clearance details

Applicant: Ems Handels Gesellschaft M.B.H.
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2017-05-11
Decision date: 2017-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Korneuburg, AT

Download summary PDF View on FDA.gov ↗

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