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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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