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FDA 510(k)

GE LOGIQ 9, MODEL 2188900-X

K-Number: K011188 · 2001-05-18

Decision Date2001-05-18
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE LOGIQ 9, MODEL 2188900-X is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 2001-05-18 under 510(k) number K011188. 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 LOGIQ 9, MODEL 2188900-X?

GE LOGIQ 9, MODEL 2188900-X is a medical device that received FDA 510(k) clearance on 2001-05-18. The listed applicant is GE Medical Systems. The 510(k) number is K011188.

When did GE LOGIQ 9, MODEL 2188900-X receive FDA 510(k) clearance?

GE LOGIQ 9, MODEL 2188900-X received FDA 510(k) clearance on 2001-05-18, under 510(k) number K011188.

Who is the listed applicant for GE LOGIQ 9, MODEL 2188900-X?

The FDA 510(k) record lists GE Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE LOGIQ 9, MODEL 2188900-X?

The FDA product code for GE LOGIQ 9, MODEL 2188900-X is IYN.

Related Clinical Trials

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.

Other records listing GE Medical Systems 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: 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.

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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