FDA 510(k) Application Details - K080175

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K080175
Device Name Gas-Machine, Anesthesia
Applicant DATASCOPE CORP., PATIENT MONITORING DIVISION
800 MACARTHUR BLVD.
MAHWAH, NJ 07430-0619 US
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Contact KATHLEEN KRAMER
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 01/24/2008
Decision Date 06/09/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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