FDA 510(k)

Leltek Ultrasound Imaging System (Model: LU700 Series)

K-Nummer: K222365 · 2022-10-25

Entscheidungsdatum2022-10-25

ProduktcodeIYN

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

Leltek Ultrasound Imaging System (Model: LU700 Series) is the device name listed in this FDA 510(k) record. The listed applicant is Leltek, Inc.. It received FDA 510(k) clearance on 2022-10-25 under 510(k) number K222365. 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 Leltek Ultrasound Imaging System (Model: LU700 Series)?

Leltek Ultrasound Imaging System (Model: LU700 Series) is a medical device that received FDA 510(k) clearance on 2022-10-25. The listed applicant is Leltek, Inc.. The 510(k) number is K222365.

When did Leltek Ultrasound Imaging System (Model: LU700 Series) receive FDA 510(k) clearance?

Leltek Ultrasound Imaging System (Model: LU700 Series) received FDA 510(k) clearance on 2022-10-25, under 510(k) number K222365.

Who is the listed applicant for Leltek Ultrasound Imaging System (Model: LU700 Series)?

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

What is the FDA product code for Leltek Ultrasound Imaging System (Model: LU700 Series)?

The FDA product code for Leltek Ultrasound Imaging System (Model: LU700 Series) is IYN.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Weitere Einträge mit Leltek, Inc. als Antragsteller

Verwandte Geräte (Code: IYN)

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.