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FDA 510(k) Application Details - K962517
Device Classification Name
Ventilator, Continuous, Non-Life-Supporting
More FDA Info for this Device
510(K) Number
K962517
Device Name
Ventilator, Continuous, Non-Life-Supporting
Applicant
HEALTHDYNE TECHNOLOGIES, INC.
1850 PARKWAY PLACE
MARIETTA, GA 30067 US
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Contact
TIMOTHY Y COWART
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
MNS
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More FDA Info for this Product Code
Date Received
06/27/1996
Decision Date
02/20/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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