Cleared Traditional

NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP

K070416 · Neoforce Group, Inc. · Anesthesiology
May 2007
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K070416 is an FDA 510(k) clearance for the NEOPEEP NEONATAL RESUSCITATION 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 May 29, 2007, 106 days after receiving the submission on February 12, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5965.

Submission Details

510(k) Number K070416 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2007
Decision Date May 29, 2007
Days to Decision 106 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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