Cleared Traditional

LONGFIAN OXYGEN CONCENTRATOR

K131968 · Longfian Scitech Co., Ltd. · Anesthesiology
Sep 2014
Decision
434d
Days
Class 2
Risk

About This 510(k) Submission

K131968 is an FDA 510(k) clearance for the LONGFIAN OXYGEN CONCENTRATOR, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Longfian Scitech Co., Ltd. (Miami, US). The FDA issued a Cleared decision on September 5, 2014, 434 days after receiving the submission on June 28, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K131968 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2013
Decision Date September 05, 2014
Days to Decision 434 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAW — Generator, Oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5440

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