SPIROX INEX DEVICE— 510(k) K132920

Substantially Equivalent

Spirox, Inc.

FDA 510(k) clearance K132920 for SPIROX INEX DEVICE, Substantially Equivalent on 2014-06-10. Applicant: Spirox, Inc.. Device class: 2.

Clearance details

Applicant: Spirox, Inc.
Product code: Code NHB
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2013-09-17
Decision date: 2014-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.