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FDA 510(k) Application Details - K051572
Device Classification Name
Spirometer, Diagnostic
More FDA Info for this Device
510(K) Number
K051572
Device Name
Spirometer, Diagnostic
Applicant
PULMONARY DATA SERVICES, INC.
908 MAIN STREET
LOUISVILLE, CO 80027 US
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Contact
DONALD HENTON
Other 510(k) Applications for this Contact
Regulation Number
868.1840
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Classification Product Code
BZG
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More FDA Info for this Product Code
Date Received
06/14/2005
Decision Date
11/17/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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