FDA 510(k)

Sienna Ultimate Wireless Amplifier

K-Number: K171397 · 2017-10-06

ApplicantEms Handels Gesellschaft M.B.H.

Decision Date2017-10-06

Product CodeGWL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Sienna Ultimate Wireless Amplifier is a medical device manufactured by Ems Handels Gesellschaft M.B.H.. It received FDA 510(k) clearance on 2017-10-06 under approval number K171397. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sienna Ultimate Wireless Amplifier?

Sienna Ultimate Wireless Amplifier is a medical device that received FDA 510(k) clearance on 2017-10-06. It is manufactured by Ems Handels Gesellschaft M.B.H.. The 510(k) number is K171397.

When was Sienna Ultimate Wireless Amplifier approved by the FDA?

Sienna Ultimate Wireless Amplifier received FDA 510(k) clearance on 2017-10-06, under approval number K171397.

What company makes Sienna Ultimate Wireless Amplifier?

Sienna Ultimate Wireless Amplifier is manufactured by Ems Handels Gesellschaft M.B.H..

What is the FDA product code for Sienna Ultimate Wireless Amplifier?

The FDA product code for Sienna Ultimate Wireless Amplifier is GWL.

Related Devices (Code: GWL)

K171669g.Nautilus PROG.Tec Medical Engineering GmbH K172312eego amplifiersEemagine Medical Imaging Solutions GmbH K2017478-CH Electroencephalography AmplifierHipposcreen Neurotech Corp. K203331Quick-20mCgx, LLC K202174Digital NeuroPort Biopotential Signal Processing SystemBlackrock Microsystems K220631NomadAir PMU810Neurotronics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.