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FDA 510(k)

GALVA-5-M

K-Number: K954411 · 1996-02-28

ApplicantZimmer Elektromedizin GmbH
Decision Date1996-02-28
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

GALVA-5-M is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Elektromedizin GmbH. It received FDA 510(k) clearance on 1996-02-28 under 510(k) number K954411. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the GALVA-5-M?

GALVA-5-M is a medical device that received FDA 510(k) clearance on 1996-02-28. The listed applicant is Zimmer Elektromedizin GmbH. The 510(k) number is K954411.

When did GALVA-5-M receive FDA 510(k) clearance?

GALVA-5-M received FDA 510(k) clearance on 1996-02-28, under 510(k) number K954411.

Who is the listed applicant for GALVA-5-M?

The FDA 510(k) record lists Zimmer Elektromedizin GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GALVA-5-M?

The FDA product code for GALVA-5-M is IPF.

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Other records listing Zimmer Elektromedizin 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.

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Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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