Cleared Traditional

PARI SINUS

K092560 · Pari Respiratory Equipment, Inc. · Anesthesiology
May 2010
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K092560 is an FDA 510(k) clearance for the PARI SINUS, 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 May 6, 2010, 259 days after receiving the submission on August 20, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K092560 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 2009
Decision Date May 06, 2010
Days to Decision 259 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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