FDA 510(k) Application Details - K003663

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K003663
Device Name Gas-Machine, Anesthesia
Applicant SPACELABS MEDICAL, INC.
P.O. BOX 97013
REDMOND, WA 98073-9713 US
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Contact IRENE JAWORSKI
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 11/28/2000
Decision Date 06/28/2001
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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