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FDA 510(k) Application Details - K091853
Device Classification Name
Spirometer, Monitoring (W/Wo Alarm)
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510(K) Number
K091853
Device Name
Spirometer, Monitoring (W/Wo Alarm)
Applicant
NSPIRE HEALTH, INC.
1830 LEFTHAND CIRCLE
LONGMONT, CO 80501 US
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Contact
KIMBERLY STARK
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Regulation Number
868.1850
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Classification Product Code
BZK
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More FDA Info for this Product Code
Date Received
06/23/2009
Decision Date
09/21/2009
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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