Cleared Special

LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050

K023805 · Laerdal Medical A/S · Anesthesiology
Feb 2003
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K023805 is an FDA 510(k) clearance for the LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050, a Valve, Non-rebreathing (Class II — Special Controls, product code CBP), submitted by Laerdal Medical A/S (Stavanger, NO). The FDA issued a Cleared decision on February 11, 2003, 89 days after receiving the submission on November 14, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number K023805 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2002
Decision Date February 11, 2003
Days to Decision 89 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBP — Valve, Non-rebreathing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5870

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