510(k) K240890

PanopticAI Vital Signs by PanopticAI technologies Limited — Product Code QME

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 23, 2024
Date Received: April 1, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Device Class: Class II
Regulation Number: 870.2785
Review Panel: CV
Submission Type

The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.

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