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FDA 510(k)

PORTI 7 PHYSIOLOGICAL AMPLIFIER

K-Number: K063599 · 2007-03-22

ApplicantTms International BV
Decision Date2007-03-22
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PORTI 7 PHYSIOLOGICAL AMPLIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Tms International BV. It received FDA 510(k) clearance on 2007-03-22 under 510(k) number K063599. 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 PORTI 7 PHYSIOLOGICAL AMPLIFIER?

PORTI 7 PHYSIOLOGICAL AMPLIFIER is a medical device that received FDA 510(k) clearance on 2007-03-22. The listed applicant is Tms International BV. The 510(k) number is K063599.

When did PORTI 7 PHYSIOLOGICAL AMPLIFIER receive FDA 510(k) clearance?

PORTI 7 PHYSIOLOGICAL AMPLIFIER received FDA 510(k) clearance on 2007-03-22, under 510(k) number K063599.

Who is the listed applicant for PORTI 7 PHYSIOLOGICAL AMPLIFIER?

The FDA 510(k) record lists Tms International BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTI 7 PHYSIOLOGICAL AMPLIFIER?

The FDA product code for PORTI 7 PHYSIOLOGICAL AMPLIFIER 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 Tms International BV 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.

K060374REFA, PHYSIOLOGICAL AMPLIFIER

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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