Cleared Traditional

DATEX AS/3 PATIENT MONITOR

K933156 · Datex Division Instrumentarium Corp. · Cardiovascular

Dec 1994

Decision

549d

Days

Class 2

Risk

About This 510(k) Submission

K933156 is an FDA 510(k) clearance for the DATEX AS/3 PATIENT MONITOR, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Datex Division Instrumentarium Corp. (Helsinki, FI). The FDA issued a Cleared decision on December 30, 1994, 549 days after receiving the submission on June 29, 1993. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number	K933156 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 1993
Decision Date	December 30, 1994
Days to Decision	549 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF