FDA 510(k) Application Details - K042253

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K042253
Device Name Ventilatory Effort Recorder
Applicant S.L.P. LTD.
18 HAZFIRA ST.
TEL-AVIV 67779 IL
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Contact NOAM HADAS
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Regulation Number 868.2375

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Classification Product Code MNR
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Date Received 08/20/2004
Decision Date 10/06/2004
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 Y
Expedited Review



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