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FDA 510(k)

GE LOGIQ P5 MODEL H44662LD

K-Number: K101878 · 2010-08-31

ApplicantGE Healthcare
Decision Date2010-08-31
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE LOGIQ P5 MODEL H44662LD is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2010-08-31 under 510(k) number K101878. 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 P5 MODEL H44662LD?

GE LOGIQ P5 MODEL H44662LD is a medical device that received FDA 510(k) clearance on 2010-08-31. The listed applicant is GE Healthcare. The 510(k) number is K101878.

When did GE LOGIQ P5 MODEL H44662LD receive FDA 510(k) clearance?

GE LOGIQ P5 MODEL H44662LD received FDA 510(k) clearance on 2010-08-31, under 510(k) number K101878.

Who is the listed applicant for GE LOGIQ P5 MODEL H44662LD?

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 GE LOGIQ P5 MODEL H44662LD?

The FDA product code for GE LOGIQ P5 MODEL H44662LD is IYN.

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Other records listing GE Healthcare 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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