Cleared Traditional

CIRCUITS, BREATHING W/CONNECTORS, ADAPT

K801875 · Airlife, Inc. · Anesthesiology
Aug 1980
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K801875 is an FDA 510(k) clearance for the CIRCUITS, BREATHING W/CONNECTORS, ADAPT, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1980, 9 days after receiving the submission on August 5, 1980. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K801875 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1980
Decision Date August 14, 1980
Days to Decision 9 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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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