Cleared Traditional

NEOPIP PATIENT CIRCUIT WITH PEEP

K103833 · Neoforce Group, Inc. · Anesthesiology
Apr 2011
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K103833 is an FDA 510(k) clearance for the NEOPIP PATIENT CIRCUIT WITH PEEP, a Attachment, Breathing, Positive End Expiratory Pressure (Class II — Special Controls, product code BYE), submitted by Neoforce Group, Inc. (Ivyland, US). The FDA issued a Cleared decision on April 20, 2011, 111 days after receiving the submission on December 30, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5965.

Submission Details

510(k) Number K103833 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2010
Decision Date April 20, 2011
Days to Decision 111 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BYE — Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5965

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