VIBRO-TRAC— 510(k) K092731

Substantially Equivalent

Pneumex, Inc.

FDA 510(k) clearance K092731 for VIBRO-TRAC, Substantially Equivalent on 2010-06-10. Applicant: Pneumex, Inc.. Device class: 2.

Clearance details

Applicant: Pneumex, Inc.
Product code: Code JFB
Device class: Class 2
Regulation: 21 CFR 890.5880
Advisory panel: Physical Medicine
Date received: 2009-09-04
Decision date: 2010-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.