Cleared Traditional

DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011

K870382 · Nova-Ventrx · Anesthesiology
Mar 1987
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K870382 is an FDA 510(k) clearance for the DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011, a Valve, Non-rebreathing (Class II — Special Controls, product code CBP), submitted by Nova-Ventrx (Wheeling, US). The FDA issued a Cleared decision on March 6, 1987, 36 days after receiving the submission on January 29, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number K870382 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1987
Decision Date March 06, 1987
Days to Decision 36 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CBP — Valve, Non-rebreathing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5870

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