Cleared Traditional

PARI VIOS

K092918 · Pari Respiratory Equipment, Inc. · Anesthesiology
Feb 2010
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K092918 is an FDA 510(k) clearance for the PARI VIOS, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Pari Respiratory Equipment, Inc. (Midlothian, US). The FDA issued a Cleared decision on February 4, 2010, 135 days after receiving the submission on September 22, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K092918 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2009
Decision Date February 04, 2010
Days to Decision 135 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

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