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FDA 510(k) Application Details - K992823
Device Classification Name
Spirometer, Diagnostic
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510(K) Number
K992823
Device Name
Spirometer, Diagnostic
Applicant
SCHILLER AG
ALTGASSE 68
BAAR CH-6341 CH
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Contact
MARKUS BUETLER
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Regulation Number
868.1840
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Classification Product Code
BZG
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Date Received
08/23/1999
Decision Date
05/12/2000
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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