FDA 510(k) Application Details - K032593

Device Classification Name Meter, Airway Pressure (Inspiratory Force)

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510(K) Number K032593
Device Name Meter, Airway Pressure (Inspiratory Force)
Applicant MERCURY MEDICAL
11300 49TH ST. NORTH
CLEARWATER, FL 33762-4800 US
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Contact WAYNE GLOVER
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Regulation Number 868.1780

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Classification Product Code BXR
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Date Received 08/22/2003
Decision Date 02/03/2004
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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