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FDA 510(k)

LOGIQ S7 Expert

K-Number: K160182 · 2016-02-26

ApplicantGE Healthcare
Decision Date2016-02-26
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LOGIQ S7 Expert is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2016-02-26 under 510(k) number K160182. 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 LOGIQ S7 Expert?

LOGIQ S7 Expert is a medical device that received FDA 510(k) clearance on 2016-02-26. The listed applicant is GE Healthcare. The 510(k) number is K160182.

When did LOGIQ S7 Expert receive FDA 510(k) clearance?

LOGIQ S7 Expert received FDA 510(k) clearance on 2016-02-26, under 510(k) number K160182.

Who is the listed applicant for LOGIQ S7 Expert?

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

What is the FDA product code for LOGIQ S7 Expert?

The FDA product code for LOGIQ S7 Expert 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 Healthcare 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.

View all 58 devices →

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.