FDA 510(k) Application Details - K952878

Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation

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510(K) Number K952878
Device Name Mixer, Breathing Gases, Anesthesia Inhalation
Applicant INFRASONICS CORP.
3911 SORRENTO VALLEY BLVD.
SAN DIEGO, CA US
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Contact JIM HITCHIN
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Regulation Number 868.5330

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Classification Product Code BZR
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Date Received 06/23/1995
Decision Date 09/25/1995
Decision SE - Substantially Equivalent
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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