FDA 510(k) Application Details - K960121

Device Classification Name Calculator, Pulmonary Function Data

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510(K) Number K960121
Device Name Calculator, Pulmonary Function Data
Applicant P.K. MORGAN LTD.
4 BLOORS LANE
KENT RAINHAM ME8 7ED GB
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Contact R.H. KERNAGHAN
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Regulation Number 868.1880

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Classification Product Code BZC
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Date Received 01/11/1996
Decision Date 01/09/1997
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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