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FDA 510(k) Application Details - K980441
Device Classification Name
Spirometer, Diagnostic
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510(K) Number
K980441
Device Name
Spirometer, Diagnostic
Applicant
NELLCOR PURITAN BENNETT, INC.
11150 THOMPSON AVE.
LENEXA, KS 66219-2301 US
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Contact
DAVID GREEN
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Regulation Number
868.1840
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Classification Product Code
BZG
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More FDA Info for this Product Code
Date Received
02/04/1998
Decision Date
04/30/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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