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MOD — Accessory To Continuous Ventilator (Respirator) Class II

FDA Device Classification

Classification Details

Product Code
MOD
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
K242485breas medicalEveryWareMay 20, 2025
K161411respironicsCare Cycle Connect ApplicationFebruary 17, 2017
K091461cardiopulmonaryBERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUEAugust 14, 2009
K052751mediserve information systemsVENTLINK SYSTEMDecember 23, 2005
K052244innovision medical technologiesIISIS, VERSION 1.0October 13, 2005
K040712air safetyAIR SAFETY HEPA, MODEL 3500June 3, 2004
K022062impact instrumentationIMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00May 6, 2003
K010401medical device groupTRI-PLEX ADAPTEROctober 30, 2002
K011861cardiopulmonaryBERNOULLI VENTILATOR MANAGEMENT SYSTEMNovember 6, 2001
K963633puritan bennettVENTNET; CENTRAL MONITORING STATIONDecember 16, 1996
K935788bicore monitoring systemsBICORE SMARTCATH INTRATRACHEAL CATHETERJuly 3, 1995
K936156smith industries medical systems (sims)VENTILATION MECHANICS MONITOR MODEL VMM-100June 27, 1995
K940739newport medical instrumentsNEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTORMarch 7, 1995