Atlas FDA

AVEA VENTILATOR

FDA 510(k) clearance K062093 · decided 2006-09-20

Clearance details

K-number
K062093
Device name
AVEA VENTILATOR
Applicant
Viasys Respiratory Care, Inc.
Decision
Substantially Equivalent
Date received
2006-07-24
Decision date
2006-09-20
Days to decision
58 days
Clearance type
Special
Product code
CBK
Device class
2
Regulation number
868.5895
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Palm Spring, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version) recall (Z-0982-2008)Viasys Respiratory Care, Inc.dba Bird Products2008-05-14
VIASYS AVEA Ventilator, Catalog numbers: 17210-03 (Italian Comprehensive Version) recall (Z-0983-2008)Viasys Respiratory Care, Inc.dba Bird Products2008-05-14
VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive Version) recall (Z-0984-2008)Viasys Respiratory Care, Inc.dba Bird Products2008-05-14
VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version) recall (Z-0985-2008)Viasys Respiratory Care, Inc.dba Bird Products2008-05-14
VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version) recall (Z-0986-2008)Viasys Respiratory Care, Inc.dba Bird Products2008-05-14