FDA 510(k) Application Details - K233872

Device Classification Name

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510(K) Number K233872
Device Name Daylight
Applicant Big Health, Inc.
461 Bush St.
Suite 200
San Francisco, CA 94108 US
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Contact Reuben Lawson
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Regulation Number

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Classification Product Code SCP
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Date Received 12/07/2023
Decision Date 08/30/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233872


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