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FDA 510(k)

GE VEO RECONSTRUCTION OPTION

K-Number: K103489 · 2011-09-09

ApplicantGeneral Electric Co.
Decision Date2011-09-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE VEO RECONSTRUCTION OPTION is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 2011-09-09 under 510(k) number K103489. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE VEO RECONSTRUCTION OPTION?

GE VEO RECONSTRUCTION OPTION is a medical device that received FDA 510(k) clearance on 2011-09-09. The listed applicant is General Electric Co.. The 510(k) number is K103489.

When did GE VEO RECONSTRUCTION OPTION receive FDA 510(k) clearance?

GE VEO RECONSTRUCTION OPTION received FDA 510(k) clearance on 2011-09-09, under 510(k) number K103489.

Who is the listed applicant for GE VEO RECONSTRUCTION OPTION?

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE VEO RECONSTRUCTION OPTION?

The FDA product code for GE VEO RECONSTRUCTION OPTION is JAK.

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Other records listing General Electric Co. 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: JAK)

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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