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FDA 510(k) Application Details - K091557
Device Classification Name
Spirometer, Therapeutic (Incentive)
More FDA Info for this Device
510(K) Number
K091557
Device Name
Spirometer, Therapeutic (Incentive)
Applicant
MEDICAL ACOUSTICS
255 GREAT ARROW AVE. STE 23
BUFFALO, NY 14207 US
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Contact
NICOLAAS J SMIT
Other 510(k) Applications for this Contact
Regulation Number
868.5690
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Classification Product Code
BWF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/27/2009
Decision Date
01/04/2010
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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