FDA 510(k) Application Details - K980876

Device Classification Name Spirometer, Diagnostic

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510(K) Number K980876
Device Name Spirometer, Diagnostic
Applicant ERICH JAEGER GMBH & CO. KG
LEIBNIZSTRASSE 7
HOECHBERG D-97204 DE
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Contact DETLEF GROTHEER
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 03/06/1998
Decision Date 08/14/1998
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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