Cleared Traditional

Seal Rite Non-Rebreathing Valve

K152521 · The Lifeguard Store, Inc. · Anesthesiology
Jun 2016
Decision
274d
Days
Class 2
Risk

About This 510(k) Submission

K152521 is an FDA 510(k) clearance for the Seal Rite Non-Rebreathing Valve, a Valve, Non-rebreathing (Class II — Special Controls, product code CBP), submitted by The Lifeguard Store, Inc. (Normal, US). The FDA issued a Cleared decision on June 3, 2016, 274 days after receiving the submission on September 3, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number K152521 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2015
Decision Date June 03, 2016
Days to Decision 274 days
Submission Type Traditional
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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