PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)— 510(k) K133263

Name: FDA 510(k) clearance K133263
Creator: U.S. Food and Drug Administration
Published: 2014-02-07

Substantially Equivalent

Proteus Digital Health, Inc.

FDA 510(k) clearance K133263 for PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY), Substantially Equivalent on 2014-02-07. 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: 2013-10-23
Decision date: 2014-02-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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