Cleared Traditional

CVERNE CAD DETECTOR

K852900 · Cherne Industries, Inc. · Cardiovascular

Sep 1985

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K852900 is an FDA 510(k) clearance for the CVERNE 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 September 25, 1985, 78 days after receiving the submission on July 9, 1985. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number	K852900 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 09, 1985
Decision Date	September 25, 1985
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—