FDA 510(k) Application Details - K001315

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K001315
Device Name Gas-Machine, Anesthesia
Applicant SIEMENS ELEMA AB
ELECTROMEDICAL SYSTEMS GROUP
16 ELECTRONICS AVENUE
DANVERS, MA 01923 US
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Contact DAVE SIMARD
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 04/26/2000
Decision Date 05/26/2000
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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