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FDA 510(k)

REFA, PHYSIOLOGICAL AMPLIFIER

K-Number: K060374 · 2006-05-30

ApplicantTms International BV
Decision Date2006-05-30
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REFA, 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 2006-05-30 under 510(k) number K060374. 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 REFA, PHYSIOLOGICAL AMPLIFIER?

REFA, PHYSIOLOGICAL AMPLIFIER is a medical device that received FDA 510(k) clearance on 2006-05-30. The listed applicant is Tms International BV. The 510(k) number is K060374.

When did REFA, PHYSIOLOGICAL AMPLIFIER receive FDA 510(k) clearance?

REFA, PHYSIOLOGICAL AMPLIFIER received FDA 510(k) clearance on 2006-05-30, under 510(k) number K060374.

Who is the listed applicant for REFA, 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 REFA, PHYSIOLOGICAL AMPLIFIER?

The FDA product code for REFA, PHYSIOLOGICAL AMPLIFIER is GWL.

Related Clinical Trials

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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.

K063599PORTI 7 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.

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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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