FDA 510(k) Application Details - K021520

Device Classification Name Ventilator, Emergency, Powered (Resuscitator)

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510(K) Number K021520
Device Name Ventilator, Emergency, Powered (Resuscitator)
Applicant EMERGENCY MEDICAL TECHOLOGY
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact GREG HOLLAND
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Regulation Number 868.5925

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Classification Product Code BTL
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Date Received 05/10/2002
Decision Date 07/15/2002
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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