Cleared Traditional

Proneb Max

K191270 · Pari Respiratory Equipment, Inc. · Anesthesiology
Jan 2020
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K191270 is an FDA 510(k) clearance for the Proneb Max, 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 January 23, 2020, 255 days after receiving the submission on May 13, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K191270 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2019
Decision Date January 23, 2020
Days to Decision 255 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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