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FDA 510(k) Application Details - K032403
Device Classification Name
Monitor, Apnea, Home Use
More FDA Info for this Device
510(K) Number
K032403
Device Name
Monitor, Apnea, Home Use
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
868.2377
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Classification Product Code
NPF
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More FDA Info for this Product Code
Date Received
08/04/2003
Decision Date
10/27/2003
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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