FDA 510(k) Application Details - K040723

Device Classification Name Meter, Peak Flow, Spirometry

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510(K) Number K040723
Device Name Meter, Peak Flow, Spirometry
Applicant MICROLIFE INTELLECTUAL PROPERTY GMBH
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 03/22/2004
Decision Date 06/10/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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