Cleared Traditional

K860869 - MEDIUM CONCENTRATION OXYGEN MASKS
(FDA 510(k) Clearance)

K860869 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology device

Mar 1986

Decision

22d

Days

Class 1

Risk

K860869 is an FDA 510(k) clearance for the MEDIUM CONCENTRATION OXYGEN MASKS. This device is classified as a Mask, Oxygen (Class I - General Controls, product code BYG).

Submitted by Dhd Medical Products Div. Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on March 19, 1986, 22 days after receiving the submission on February 25, 1986.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number	K860869 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 25, 1986
Decision Date	March 19, 1986
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—