Cleared Traditional

RES-Q 1, 2, 3, 4 AND 5

K881207 · Nova-Ventrx · Anesthesiology
Aug 1988
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K881207 is an FDA 510(k) clearance for the RES-Q 1, 2, 3, 4 AND 5, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Nova-Ventrx (Wheeling, US). The FDA issued a Cleared decision on August 15, 1988, 147 days after receiving the submission on March 21, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K881207 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1988
Decision Date August 15, 1988
Days to Decision 147 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BTM — Ventilator, Emergency, Manual (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5915

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