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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 the device name listed in this FDA 510(k) record. The listed applicant is Ems Handels Gesellschaft M.B.H.. It received FDA 510(k) clearance on 2017-10-06 under 510(k) 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. The listed applicant is Ems Handels Gesellschaft M.B.H.. The 510(k) number is K171397.

When did Sienna Ultimate Wireless Amplifier receive FDA 510(k) clearance?

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

Who is the listed applicant for Sienna Ultimate Wireless Amplifier?

The FDA 510(k) record lists Ems Handels Gesellschaft M.B.H. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243746Delphi AmplifierQuantalx NeroscienceK242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.K240646DreamClearSomnomed Technologies Inc., Doing Business AS RemwareK232210X-trodes System MX-TrodesK230148VlabDormotech Medical, Ltd.

Official Source

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

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