Cleared Traditional

ISPIRA RESUSCITATION UNIT

K092085 · Neoforce Group, Inc. · Anesthesiology
Oct 2009
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K092085 is an FDA 510(k) clearance for the ISPIRA RESUSCITATION UNIT, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Neoforce Group, Inc. (Ivyland, US). The FDA issued a Cleared decision on October 7, 2009, 90 days after receiving the submission on July 9, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K092085 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2009
Decision Date October 07, 2009
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTL — Ventilator, Emergency, Powered (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5925

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