FDA 510(k) Application Details - K961252

Device Classification Name Calculator, Predicted Values, Pulmonary Function

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510(K) Number K961252
Device Name Calculator, Predicted Values, Pulmonary Function
Applicant INAIR LTD.
P.O. BOX 126
DELMAR, NY 12054 US
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Contact HAROLD W TOMLINSON
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Regulation Number 868.1890

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Classification Product Code BTY
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Date Received 04/01/1996
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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