Cleared Traditional

NEBULIZER (DIRECT PATIENT INTERFACE)

K915075 · Medi Nuclear Corp., Inc. · Anesthesiology
Jul 1992
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K915075 is an FDA 510(k) clearance for the NEBULIZER (DIRECT PATIENT INTERFACE), 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 16, 1992, 251 days after receiving the submission on November 8, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K915075 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1991
Decision Date July 16, 1992
Days to Decision 251 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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