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MNT — Ventilator, Continuous, Minimal Ventilatory Support, Facility Use Class II

FDA Device Classification

Classification Details

Product Code
MNT
Device Class
Class II
Regulation Number
868.5895
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242931mekics coHFT750UMay 15, 2025
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K170367fisher and paykel healthcare limitedNivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - LargeAugust 24, 2017
K122715resmed germanySTELLAR 150June 17, 2013
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K113640resmed germanySTELLAR 150April 5, 2012
K102985respironicsV60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONSApril 5, 2011
K103167resmed germanySTELLAR 150March 1, 2011
K090113breas medicalBREAS VIVO 40 SYSTEMMay 14, 2009
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K071702breas medicalBREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40February 15, 2008
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K053607breas medicalBREAS VIVO 40 SYSTEMMarch 16, 2006
K003075mallinckrodtKNIGHTSTAR 330 VENTILATORDecember 11, 2001
K990574respironicsSTICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964May 24, 1999
K982454respironicsBIPAP VISION VENTILATORY SUPPORTNovember 3, 1998