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510(k) K243966

FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) by Faceheart Corp. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2025
Date Received
December 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Faceheart Corp.

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