FDA 510(k)

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)

K-Nummer: K242769 · 2025-04-04

Entscheidungsdatum2025-04-04

ProduktcodeBTL

BeratungsausschussAN

EntscheidungSubstantially Equivalent

Produktübersicht

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) is the device name listed in this FDA 510(k) record. The listed applicant is Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K242769. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)?

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Draegerwerk AG & CO Kgaa. The 510(k) number is K242769.

When did VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) receive FDA 510(k) clearance?

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K242769.

Who is the listed applicant for VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)?

The FDA 510(k) record lists Draegerwerk AG & CO Kgaa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)?

The FDA product code for VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) is BTL.

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 Draegerwerk AG & CO Kgaa als Antragsteller

K253647Evita (V800); Evita (V600)K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)K222024Evita V800, Evita V600 K222207Babylog VN800, Babylog VN600 K221118CO2 Mainstream Sensor K162821Babyleo TN500

Alle 7 Geräte anzeigen →

Verwandte Geräte (Code: BTL)

K221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A K202219VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc.K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagWeinmann Emergency Medical Technology GmbH + Co. KG K182956Puffin Lite Infant Resuscitation SystemInternational Biomedical K173373SafeT T-Piece ResuscitatorVentlab, LLC K161420MOVES SLCThornhill Research, Inc.

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.