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OZWClass II

Ingestible Event Marker

21 CFR 880.6305 / General Hospital
FDA source (opens on fda.gov)

OZW is the FDA product code for Ingestible Event Marker, a class II device type, regulated under 21 CFR 880.6305. FDA's definition for this code reads: "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". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OZW
Device name
Ingestible Event Marker
FDA definition
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
Regulation
21 CFR 880.6305
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code OZW

By decision year
8 clearances under product code OZW with a decision year between 2012 and 2025, 2013 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OZW by decision year
YearClearances
20121
20132
20141
20151
20191
20231
20251

Applicants with the most clearances

Product code OZW
Applicants holding the most 510(k) clearances under product code OZW
ApplicantClearances
Proteus Digital Health, Inc.4
Otsuka America Pharmaceutical, Inc2
Etectrx, Inc.1
Proteus Biomedical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code