FDA 510(k) Application Details - K062224

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K062224
Device Name Ventilator, Non-Continuous (Respirator)
Applicant RESPCARE INC.
6601 LYONS ROAD, SUITES B1-B4
COCONUT CREEK, FL 33073 US
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Contact FRANK PELC
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 08/02/2006
Decision Date 08/17/2006
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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