FDA 510(k) Applications for Medical Device Product Code "MOD"
(Accessory To Continuous Ventilator (Respirator))

FDA 510(k) Number Applicant Device Name Decision Date
K040712 AIR SAFETY LTD AIR SAFETY HEPA, MODEL 3500 06/03/2004
K091461 CARDIOPULMONARY CORP. BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE 08/14/2009
K011861 CARDIOPULMONARY CORP. BERNOULLI VENTILATOR MANAGEMENT SYSTEM 11/06/2001
K022062 IMPACT INSTRUMENTATION, INC. IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 05/06/2003
K052244 INNOVISION MEDICAL TECHNOLOGIES, LLC IISIS, VERSION 1.0 10/13/2005
K052751 MEDISERVE INFORMATION SYSTEMS, INC. VENTLINK SYSTEM 12/23/2005
K963633 PURITAN BENNETT CORP. VENTNET; CENTRAL MONITORING STATION 12/16/1996
K161411 RESPIRONICS, INC. Care Cycle Connect Application 02/17/2017
K010401 THE MEDICAL DEVICE GROUP, INC. TRI-PLEX ADAPTER 10/30/2002


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