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FDA 510(k) Application Details - K072996
Device Classification Name
Ventilator, Non-Continuous (Respirator)
More FDA Info for this Device
510(K) Number
K072996
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
RESPIRONICS, INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE, PA 15146 US
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Contact
ZITA A YURKO
Other 510(k) Applications for this Contact
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
10/24/2007
Decision Date
12/27/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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