inforMED
OZWClass II

Ingestible Event Marker

General Hospital · 21 CFR 880.6305

To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computing device

MDR events2All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances8All time

Recent MDR events

2 adverse event reports on file

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Event type breakdown

Death2

Most-reported manufacturers

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Proteus1Proteus Digital Health, Inc1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

1 firms currently registered for this product code

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510(k) clearances

8 clearances for this product code

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