FDA 510(k) Application Details - K040380

Device Classification Name Oximeter

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510(K) Number K040380
Device Name Oximeter
Applicant DOLPHIN MEDICAL INC.
14240 N. 42ND STREET
APT 205
TAMPA, FL 33613 US
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Contact JON WERNER
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 02/17/2004
Decision Date 08/31/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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