Cleared Traditional

CANARY BREATHING SYSTEM

K131586 · Palo Alto Health Sciences, Inc. · Neurology
Dec 2013
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K131586 is an FDA 510(k) clearance for the CANARY BREATHING SYSTEM, a Device, Biofeedback (Class II — Special Controls, product code HCC), submitted by Palo Alto Health Sciences, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 10, 2013, 193 days after receiving the submission on May 31, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K131586 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2013
Decision Date December 10, 2013
Days to Decision 193 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCC — Device, Biofeedback
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050