Cleared Traditional

HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510

K080969 · Medi Nuclear Corp., Inc. · Anesthesiology
Jul 2008
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K080969 is an FDA 510(k) clearance for the HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Medi Nuclear Corp., Inc. (Baldwin Park, US). The FDA issued a Cleared decision on July 25, 2008, 112 days after receiving the submission on April 4, 2008. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K080969 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2008
Decision Date July 25, 2008
Days to Decision 112 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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