FDA 510(k) Application Details - K152276

Device Classification Name Meter, Peak Flow, Spirometry

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510(K) Number K152276
Device Name Meter, Peak Flow, Spirometry
Applicant Sparo Inc.
911 Washington Ave, #809
Saint Louis, MO 63101 US
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Contact Mona Dean
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Regulation Number 868.1860

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Classification Product Code BZH
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Date Received 08/12/2015
Decision Date 06/03/2016
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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