CANARY BREATHING SYSTEM— 510(k) K131586

Name: FDA 510(k) clearance K131586
Creator: U.S. Food and Drug Administration
Published: 2013-12-10

Substantially Equivalent

Palo Alto Health Sciences, Inc.

FDA 510(k) clearance K131586 for CANARY BREATHING SYSTEM, Substantially Equivalent on 2013-12-10. Applicant: Palo Alto Health Sciences, Inc.. Device class: 2.

Clearance details

Applicant: Palo Alto Health Sciences, Inc.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 2013-05-31
Decision date: 2013-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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