Cleared Traditional

AS/3 LIGHT MONITOR

K961247 · Datex Division Instrumentarium Corp. · Cardiovascular

Oct 1996

Decision

205d

Days

Class 2

Risk

About This 510(k) Submission

K961247 is an FDA 510(k) clearance for the AS/3 LIGHT MONITOR, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Datex Division Instrumentarium Corp. (Tewksbury, US). The FDA issued a Cleared decision on October 23, 1996, 205 days after receiving the submission on April 1, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number	K961247 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 1996
Decision Date	October 23, 1996
Days to Decision	205 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF