inforMED
QMEClass II

Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate

Cardiovascular · 21 CFR 870.2785

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.

MDR events0All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances13All time

Recent MDR events

0 adverse event reports on file

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No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

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No data available.

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

6 firms currently registered for this product code

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510(k) clearances

13 clearances for this product code

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