Cleared Traditional

MODIFIED CHERNE CAD DETECTOR

K860015 · Cherne Industries, Inc. · Cardiovascular

Apr 1986

Decision

110d

Days

Class 2

Risk

About This 510(k) Submission

K860015 is an FDA 510(k) clearance for the MODIFIED CHERNE CAD DETECTOR, a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Cherne Industries, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 23, 1986, 110 days after receiving the submission on January 3, 1986. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number	K860015 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 03, 1986
Decision Date	April 23, 1986
Days to Decision	110 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—