FDA 510(k) Application Details - K030985

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K030985
Device Name Ventilator, Non-Continuous (Respirator)
Applicant VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA, NJ 07512 US
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Contact ANTHONY P MARTINO
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 03/28/2003
Decision Date 10/15/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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