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510(k) K123144

Device
VIVO 50
Applicant
GE HEALTHCARE, BREAS MEDICAL AB
510(k) number
K123144
Product code
NOU  
Decision
Substantially Equivalent (SESE)
Decision date
2013-06-18
Date received
2012-10-05
Regulation
868.5895
Classification name
Continuous, Ventilator, Home Use
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SHLOMI DELER
Address
Foretagsvagen 1 Molnlycke SE 435 33 435 33

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NOU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233452Vivo 45 LSBreas Medical AB2025-01-13
K193586Vivo 45 LSBreas Medical AB2021-01-27
K160481Vivo 60Breas Medical AB2016-11-09
K034032PLV CONTINUUM VENTILATOR, MODEL P2000Respironics California, Inc.2004-03-16
K022750PLV CONTINUUM VENTILATOR, MODEL P1000Respironics California, Inc.2003-11-20
K021981IVENT 201 PORTABLE VENTILATORVersamed , Ltd.2003-08-13

Legacy Summary#

summary

FDA Review#

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