Cleared Traditional

K860879 - DISPOSABLE VENTILATOR CIRCUITS
(FDA 510(k) Clearance)

K860879 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology device

Mar 1986

Decision

23d

Days

Class 1

Risk

K860879 is an FDA 510(k) clearance for the DISPOSABLE VENTILATOR CIRCUITS. This device is classified as a Set, Tubing And Support, Ventilator (w Harness) (Class I - General Controls, product code BZO).

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 FDA review panel. Regulated under 21 CFR 868.5975.

Submission Details

510(k) Number	K860879 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 25, 1986
Decision Date	March 20, 1986
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—