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Ingestible Event Marker

FDA product code OZW · 5 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.6305
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2013-05-07 – 2025-06-30

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

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