PROTEUS PATCH INCLUDING INGESTIBLE SENSOR— 510(k) K131524

Name: FDA 510(k) clearance K131524
Creator: U.S. Food and Drug Administration
Published: 2013-06-23

Substantially Equivalent

Proteus Digital Health, Inc.

FDA 510(k) clearance K131524 for PROTEUS PATCH INCLUDING INGESTIBLE SENSOR, Substantially Equivalent on 2013-06-23. Applicant: Proteus Digital Health, Inc.. Device class: 2.

Clearance details

Applicant: Proteus Digital Health, Inc.
Product code: Code OZW
Device class: Class 2
Regulation: 21 CFR 880.6305
Advisory panel: General Hospital
Date received: 2013-05-28
Decision date: 2013-06-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OZW

view all

K251088 — Otsuka Digital Feedback Device2025-06-30
K223463 — Otsuka Digital Feedback Device-RW2023-08-11
K183052 — ID-Cap System2019-12-06
K150494 — Proteus Digital Health Feedback Device2015-06-27
K133263 — PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)2014-02-07

More clearances from Proteus Digital Health, Inc.

view all

K131009 — PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)2013-05-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.