FDA 510(k) Application Details - DEN200011

Device Classification Name

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510(K) Number DEN200011
Device Name Masimo SafetyNet
Applicant Masimo Corporation
52 Discovery
Irvine, CA 91628 US
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Contact Linus Park
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Regulation Number

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Classification Product Code QVT
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Date Received 02/19/2020
Decision Date 03/31/2023
Decision DENG -
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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