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FDA 510(k) Application Details - K140772
Device Classification Name
Spirometer, Therapeutic (Incentive)
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510(K) Number
K140772
Device Name
Spirometer, Therapeutic (Incentive)
Applicant
Actegy Ltd
555 13TH STREET, NW
WASHINGTON, DC 20004 US
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Contact
John j Smith, M.D., J.D.
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Regulation Number
868.5690
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Classification Product Code
BWF
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More FDA Info for this Product Code
Date Received
03/27/2014
Decision Date
12/19/2014
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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