Ingestible Event Marker

OZW · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6305

Classification

FDA Product Code: OZW
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.6305
Review panel: CV
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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

Market data

Cleared 510(k) submissions: 8
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown