Cleared Traditional

VENTURI MASK/ADULT & PAEDIATRIC

K860873 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology
Mar 1986
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K860873 is an FDA 510(k) clearance for the VENTURI MASK/ADULT & PAEDIATRIC, a Mask, Oxygen, Low Concentration, Venturi (Class I — General Controls, product code BYF), submitted by Dhd Medical Products Div. Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on March 20, 1986, 23 days after receiving the submission on February 25, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5600.

Submission Details

510(k) Number K860873 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1986
Decision Date March 20, 1986
Days to Decision 23 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BYF — Mask, Oxygen, Low Concentration, Venturi
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5600

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