Sienna Ultimate Wireless Amplifier

FDA 510(k) K171397 · Ems Handels Gesellschaft M.B.H.

Substantially Equivalent

510(k) numberK171397

Submission

Device name
Sienna Ultimate Wireless Amplifier
Applicant
Ems Handels Gesellschaft M.B.H.
Korneuburg, AT
Received
May 11, 2017
Decision date
October 6, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWL – Amplifier, Physiological Signal
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1835
Specialty
Neurology

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Questions and answers

When was Sienna Ultimate Wireless Amplifier cleared by the FDA?

Sienna Ultimate Wireless Amplifier (K171397) received a 510(k) decision of Substantially Equivalent on October 6, 2017, 148 days after the submission was received.

What is the product code of K171397?

The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.