FDA 510(k) Application Details - K973646

Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation

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510(K) Number K973646
Device Name Mixer, Breathing Gases, Anesthesia Inhalation
Applicant BIRD PRODUCTS CORP.
1100 BIRD CENTER DR.
PALM SPRINGS, CA 92262 US
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Contact NEIL BATTISTE
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Regulation Number 868.5330

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Classification Product Code BZR
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Date Received 09/24/1997
Decision Date 05/07/1998
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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