Cleared Traditional

HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM

K082541 · Medi Nuclear Corp., Inc. · Anesthesiology
Nov 2008
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K082541 is an FDA 510(k) clearance for the HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM, 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 November 26, 2008, 85 days after receiving the submission on September 2, 2008. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K082541 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2008
Decision Date November 26, 2008
Days to Decision 85 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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