APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM— 510(k) K073265

Name: FDA 510(k) clearance K073265
Creator: U.S. Food and Drug Administration
Published: 2008-03-14

Substantially Equivalent

Apieron, Inc.

FDA 510(k) clearance K073265 for APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM, Substantially Equivalent on 2008-03-14. Applicant: Apieron, Inc.. Device class: 2.

Clearance details

Applicant: Apieron, Inc.
Product code: Code MXA
Device class: Class 2
Regulation: 21 CFR 862.3080
Advisory panel: Clinical Toxicology
Date received: 2007-11-20
Decision date: 2008-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

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