Proteus Digital Health Feedback Device— 510(k) K150494

Name: FDA 510(k) clearance K150494
Creator: U.S. Food and Drug Administration
Published: 2015-06-27

Substantially Equivalent

Proteus Digital Health, Inc.

FDA 510(k) clearance K150494 for Proteus Digital Health Feedback Device, Substantially Equivalent on 2015-06-27. 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: 2015-02-25
Decision date: 2015-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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