APIERON INSIGHT ENO SYSTEM— 510(k) K083617

Substantially Equivalent

Apieron, Inc.

FDA 510(k) clearance K083617 for APIERON INSIGHT ENO SYSTEM, Substantially Equivalent on 2009-01-27. 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: 2008-12-08
Decision date: 2009-01-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

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