Cleared Traditional

Airvo Nebulizer Adapter

K211560 · Fisher & Paykel Healthcare Limited · Anesthesiology
Dec 2021
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K211560 is an FDA 510(k) clearance for the Airvo Nebulizer Adapter, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Fisher & Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on December 10, 2021, 204 days after receiving the submission on May 20, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K211560 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2021
Decision Date December 10, 2021
Days to Decision 204 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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