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FDA 510(k) Application Details - K043006
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K043006
Device Name
Generator, Oxygen, Portable
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE, PA 15668 US
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Contact
ZITA A YURKO
Other 510(k) Applications for this Contact
Regulation Number
868.5440
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Classification Product Code
CAW
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More FDA Info for this Product Code
Date Received
11/01/2004
Decision Date
02/11/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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