Cleared Traditional

ERAPID NEBULIZER SYSTEM

K112859 · Pari Respiratory Equipment, Inc. · Anesthesiology
May 2012
Decision
243d
Days
Class 2
Risk

About This 510(k) Submission

K112859 is an FDA 510(k) clearance for the ERAPID NEBULIZER SYSTEM, 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 30, 2012, 243 days after receiving the submission on September 30, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K112859 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2011
Decision Date May 30, 2012
Days to Decision 243 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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