FDA 510(k)

Barrier EasyWarm Active Self-Warming Blanket

K-Nummer: K232508 · 2023-09-15

AntragstellerMolnlycke Health Care Us, LLC

Entscheidungsdatum2023-09-15

ProduktcodeDWJ

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

Barrier EasyWarm Active Self-Warming Blanket is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K232508. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Barrier EasyWarm Active Self-Warming Blanket?

Barrier EasyWarm Active Self-Warming Blanket is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K232508.

When did Barrier EasyWarm Active Self-Warming Blanket receive FDA 510(k) clearance?

Barrier EasyWarm Active Self-Warming Blanket received FDA 510(k) clearance on 2023-09-15, under 510(k) number K232508.

Who is the listed applicant for Barrier EasyWarm Active Self-Warming Blanket?

The FDA 510(k) record lists Molnlycke Health Care Us, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Barrier EasyWarm Active Self-Warming Blanket?

The FDA product code for Barrier EasyWarm Active Self-Warming Blanket is DWJ.

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 Molnlycke Health Care Us, LLC als Antragsteller

K203369Avance Solo Negative Pressure Wound Therapy (NPWT) System K202090Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro K191869Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove K161939Avance Abdominal Dressing Kit

Alle 12 Geräte anzeigen →

Verwandte Geräte (Code: DWJ)

K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life K260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbH K260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arktischer Sonne Temperaturmanagement-System (Modell 5000)Medivance, 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.