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FDA 510(k) Application Details - K983909
Device Classification Name
Spirometer, Diagnostic
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510(K) Number
K983909
Device Name
Spirometer, Diagnostic
Applicant
MIR MEDICAL INTL. RESEARCH SRL
VICOLO MADDALENA 22/A
ALBANO LAZIALE, ROMA 00041 IT
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SIMON FOWLER
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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
11/03/1998
Decision Date
12/21/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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