Cleared Traditional

BABYAIR

K060497 · Promedic, Inc. · Anesthesiology
Jul 2006
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K060497 is an FDA 510(k) clearance for the BABYAIR, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Promedic, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on July 11, 2006, 137 days after receiving the submission on February 24, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K060497 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2006
Decision Date July 11, 2006
Days to Decision 137 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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