inforMED
QDBClass II

Photoplethysmograph Analysis Software For Over-the-counter Use

Cardiovascular · 21 CFR 870.2790

A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.

MDR events1All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances5All time

Recent MDR events

1 adverse event reports on file

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Event type breakdown

Malfunction1

Most-reported manufacturers

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Fitbit Llc/google1

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

5 clearances for this product code

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