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FDA 510(k)

GE VENUE 40, MODEL 5324338

K-Number: K091164 · 2009-05-05

ApplicantGe Medical Systems China Co., Ltd.
Decision Date2009-05-05
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE VENUE 40, MODEL 5324338 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems China Co., Ltd.. It received FDA 510(k) clearance on 2009-05-05 under 510(k) number K091164. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE VENUE 40, MODEL 5324338?

GE VENUE 40, MODEL 5324338 is a medical device that received FDA 510(k) clearance on 2009-05-05. The listed applicant is Ge Medical Systems China Co., Ltd.. The 510(k) number is K091164.

When did GE VENUE 40, MODEL 5324338 receive FDA 510(k) clearance?

GE VENUE 40, MODEL 5324338 received FDA 510(k) clearance on 2009-05-05, under 510(k) number K091164.

Who is the listed applicant for GE VENUE 40, MODEL 5324338?

The FDA 510(k) record lists Ge Medical Systems China Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE VENUE 40, MODEL 5324338?

The FDA product code for GE VENUE 40, MODEL 5324338 is IYN.

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Other records listing Ge Medical Systems China Co., Ltd. as applicant

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Related Devices (Code: IYN)

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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