FDA 510(k) Application Details - K952429

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K952429
Device Name Ventilator, Non-Continuous (Respirator)
Applicant RESCARE LTD.
3377 NORTH TORREY PINES COURT
SUITE 300
LA JOLLA, CA 92037 US
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Contact ALAN DONALD
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 05/24/1995
Decision Date 07/02/1996
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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