FDA 510(k)

LOGIQ E10s, LOGIQ Fortis

K-Nummer: K231989 · 2023-11-07

AntragstellerGe Medical Systems Ultrasound and Primary Care Diagnostic,

Entscheidungsdatum2023-11-07

ProduktcodeIYN

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

LOGIQ E10s, LOGIQ Fortis is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnostic,. It received FDA 510(k) clearance on 2023-11-07 under 510(k) number K231989. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the LOGIQ E10s, LOGIQ Fortis?

LOGIQ E10s, LOGIQ Fortis is a medical device that received FDA 510(k) clearance on 2023-11-07. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnostic,. The 510(k) number is K231989.

When did LOGIQ E10s, LOGIQ Fortis receive FDA 510(k) clearance?

LOGIQ E10s, LOGIQ Fortis received FDA 510(k) clearance on 2023-11-07, under 510(k) number K231989.

Who is the listed applicant for LOGIQ E10s, LOGIQ Fortis?

The FDA 510(k) record lists Ge Medical Systems Ultrasound and Primary Care Diagnostic, as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOGIQ E10s, LOGIQ Fortis?

The FDA product code for LOGIQ E10s, LOGIQ Fortis is IYN.

Zugehörige klinische Studien

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Weitere Einträge mit Ge Medical Systems Ultrasound and Primary Care Diagnostic, als Antragsteller

K232186LOGIQ e

Verwandte Geräte (Code: IYN)

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