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FDA PRODUCT CODE · CLASS II

OZW — Ingestible Event Marker

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

DEVICE CLASS
Class II
REGULATION
21 CFR 880.6305
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K251088Otsuka America Pharmaceutical, Inc. · 510k2025-06-30

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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