FDA 510(k) Application Details - K031024

Device Classification Name Meter, Peak Flow, Spirometry

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510(K) Number K031024
Device Name Meter, Peak Flow, Spirometry
Applicant MICROLIFE CORP.
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 868.1860

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Classification Product Code BZH
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Date Received 03/31/2003
Decision Date 11/14/2003
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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