FDA 510(k) Application Details - K992788

Device Classification Name Ventilator, Continuous, Facility Use

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510(K) Number K992788
Device Name Ventilator, Continuous, Facility Use
Applicant BEAR MEDICAL SYSTEMS, INC.
1100 BIRD CENTER DR.
PALM SPRINGS, CA 92262 US
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Contact DARRYL SHELBY
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Regulation Number 868.5895

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Classification Product Code CBK
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Date Received 08/19/1999
Decision Date 09/16/1999
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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