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FDA 510(k) Application Details - K983274
Device Classification Name
Spirometer, Monitoring (W/Wo Alarm)
More FDA Info for this Device
510(K) Number
K983274
Device Name
Spirometer, Monitoring (W/Wo Alarm)
Applicant
NELLCOR PURITAN BENNETT, INC.
11150 THOMPSON AVE.
LENEXA, KS 66219-2301 US
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Contact
DAVID A.C. GREEN
Other 510(k) Applications for this Contact
Regulation Number
868.1850
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Classification Product Code
BZK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/17/1998
Decision Date
12/09/1998
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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