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510(k) K052244

Device
IISIS, VERSION 1.0
Applicant
Innovision Medical Technologies, LLC
510(k) number
K052244
Product code
MOD
Decision
Substantially Equivalent (SESE)
Decision date
2005-10-13
Date received
2005-08-17
Regulation
868.5895
Classification name
Accessory To Continuous Ventilator (Respirator)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
PATRICIA L ANDREWS
Address
1302 Concourse Dr. Suite 302 Linthicum MD US 21090 21090

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K091461BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUECardiopulmonary Corp.2009-08-14
K052751VENTLINK SYSTEMMediserve Information Systems, Inc.2005-12-23
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K010401TRI-PLEX ADAPTERThe Medical Device Group, Inc.2002-10-30
K011861BERNOULLI VENTILATOR MANAGEMENT SYSTEMCardiopulmonary Corp.2001-11-06
K963633VENTNET; CENTRAL MONITORING STATIONPuritan Bennett Corp.1996-12-16
K935788BICORE SMARTCATH INTRATRACHEAL CATHETERBicore Monitoring Systems1995-07-03
K936156VENTILATION MECHANICS MONITOR MODEL VMM-100Smith Industries Medical Systems (Sims)1995-06-27
K940739NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTORNewport Medical Instruments, Inc.1995-03-07