Cleared Traditional

Magneto Nasal Mask

K210386 · Respironics, Inc. · Anesthesiology
Jul 2021
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K210386 is an FDA 510(k) clearance for the Magneto Nasal Mask, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on July 12, 2021, 153 days after receiving the submission on February 9, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K210386 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2021
Decision Date July 12, 2021
Days to Decision 153 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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