Sienna Ultimate Wireless Amplifier— 510(k) K171397

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..

Clearance details

Applicant
Ems Handels Gesellschaft M.B.H.
Product code
Code GWL
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Korneuburg, AT
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