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FDA 510(k) Application Details - K974879
Device Classification Name
Ventilator, Non-Continuous (Respirator)
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510(K) Number
K974879
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
HEALTHDYNE TECHNOLOGIES, INC.
1850 PARKWAY PLACE
MARIETTA, GA 30067 US
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Contact
TIMOTHY Y COWART
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Regulation Number
868.5905
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Classification Product Code
BZD
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More FDA Info for this Product Code
Date Received
12/30/1997
Decision Date
06/29/1998
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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