510(k) K183052

ID-Cap System by Etectrx, Inc. — Product Code OZW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 6, 2019
Date Received: November 2, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Ingestible Event Marker
Device Class: Class II
Regulation Number: 880.6305
Review Panel: CV
Submission Type

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

Other clearances for product code OZW

K251088 — Otsuka Digital Feedback Device (June 30, 2025)
K223463 — Otsuka Digital Feedback Device-RW (August 11, 2023)
K150494 — Proteus Digital Health Feedback Device (June 27, 2015)
K133263 — PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) (February 7, 2014)
K131524 — PROTEUS PATCH INCLUDING INGESTIBLE SENSOR (June 23, 2013)
K131009 — PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) (May 7, 2013)
DEN120011 — PROTEUS INGESTION CONFINMATION SYSTEMS (July 10, 2012)