FDA 510(k) Application Details - K002787

Device Classification Name Oximeter

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510(K) Number K002787
Device Name Oximeter
Applicant PALCO LABS, INC.
8030 SOQUEL AVE.
SANTA CRUZ, CA 95062 US
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Contact RICHELLA GOO
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 09/07/2000
Decision Date 11/29/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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