Cleared Traditional

RAIN-X

K812737 · Nova-Ventrx · Anesthesiology
Oct 1981
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K812737 is an FDA 510(k) clearance for the RAIN-X, a Set, Tubing And Support, Ventilator (w Harness) (Class I — General Controls, product code BZO), submitted by Nova-Ventrx (Mchenry, US). The FDA issued a Cleared decision on October 23, 1981, 24 days after receiving the submission on September 29, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5975.

Submission Details

510(k) Number K812737 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 1981
Decision Date October 23, 1981
Days to Decision 24 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BZO — Set, Tubing And Support, Ventilator (w Harness)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5975