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FDA 510(k) Application Details - K073069
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K073069
Device Name
Ventilator, Continuous, Facility Use
Applicant
VIASYS RESPIRATORY CARE INC
1100 BIRD CENTER DR.
PALM SPRINGS, CA 92262 US
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Contact
TOM GUTIERREZ
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
CBK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/30/2007
Decision Date
01/25/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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