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FDA 510(k) Application Details - K103575
Device Classification Name
Spirometer, Diagnostic
More FDA Info for this Device
510(K) Number
K103575
Device Name
Spirometer, Diagnostic
Applicant
PMD HEALTHCARE
1468 HARWELL AVE.
CROFTON, MD 21114 US
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Contact
E.J. Smith
Other 510(k) Applications for this Contact
Regulation Number
868.1840
More FDA Info for this Regulation Number
Classification Product Code
BZG
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More FDA Info for this Product Code
Date Received
12/06/2010
Decision Date
11/09/2011
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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