FDA 510(k) Application Details - K031470

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K031470
Device Name Ventilator, Non-Continuous (Respirator)
Applicant TYCO HEALTHCARE NANCY
NELLCOR PURITAN BENNETT DIV.
4280 HACIENDA DRIVE
PLEASANTON, CA 94588 US
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Contact JAMES BONDS
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 05/09/2003
Decision Date 06/05/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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