FDA 510(k) Application Details - K963131

Device Classification Name Spirometer, Diagnostic

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510(K) Number K963131
Device Name Spirometer, Diagnostic
Applicant GRASEBY ANDERSEN
500 TECHNOLOGY CT.
SMYRNA, GA 30082 US
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Contact JESS KASH
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 08/12/1996
Decision Date 02/14/1997
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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