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FDA 510(k)

g.HIamp

K-Number: K123255 · 2012-12-20

ApplicantG.Tec Medical Engineering GmbH
Decision Date2012-12-20
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

g.HIamp is the device name listed in this FDA 510(k) record. The listed applicant is G.Tec Medical Engineering GmbH. It received FDA 510(k) clearance on 2012-12-20 under 510(k) number K123255. 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 g.HIamp?

g.HIamp is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is G.Tec Medical Engineering GmbH. The 510(k) number is K123255.

When did g.HIamp receive FDA 510(k) clearance?

g.HIamp received FDA 510(k) clearance on 2012-12-20, under 510(k) number K123255.

Who is the listed applicant for g.HIamp?

The FDA 510(k) record lists G.Tec Medical Engineering GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for g.HIamp?

The FDA product code for g.HIamp is GWL.

Related Clinical Trials

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.

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Other records listing G.Tec Medical Engineering GmbH as applicant

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.

K200088g.Estim FESK191432cortiQ PROK173684g.Estim PROK171669g.Nautilus PROK060803G.USBAMP

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

View on FDA Database →

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

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