FDA 510(k) Application Details - K011518

Device Classification Name Oximeter

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510(K) Number K011518
Device Name Oximeter
Applicant BETA BIOMED SERVICES, INC.
1468 HARWELL AVE.
CROFTON, MD 21114 US
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Contact E J SMITH
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 05/17/2001
Decision Date 11/15/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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