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FDA 510(k)

GALVA 5-T

K-Number: K960969 · 1996-05-15

ApplicantZimmer Elektromedizin GmbH
Decision Date1996-05-15
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GALVA 5-T 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 1996-05-15 under 510(k) number K960969. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALVA 5-T?

GALVA 5-T is a medical device that received FDA 510(k) clearance on 1996-05-15. The listed applicant is Zimmer Elektromedizin GmbH. The 510(k) number is K960969.

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

GALVA 5-T received FDA 510(k) clearance on 1996-05-15, under 510(k) number K960969.

Who is the listed applicant for GALVA 5-T?

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-T?

The FDA product code for GALVA 5-T is GZJ.

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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: GZJ)

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

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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