Medical Device Manufacturer · US , Tewksbury , MA

Datex-Engstrom, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1998

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Datex-Engstrom, Inc. Cardiovascular ✕

6 devices

1-6 of 6

Cleared Dec 22, 1998

CS/3 COMPACT AIRWAY MODULE, M-COVX

Cardiovascular · 190d

Cleared Nov 03, 1998

DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1

Cardiovascular · 201d

Cleared Jun 30, 1998

MRI COMPATIBLE MONITOR AND ACCESSORIES

Cardiovascular · 152d

Cleared Jun 02, 1998

CS/3(TM) MONITORS*

Cardiovascular · 162d

Cleared Apr 23, 1998

CS/3 ARRHYTHMIA WORKSTATION

Cardiovascular · 125d

Cleared Feb 06, 1998

DATEX-ENGSTROM NETWORK

Cardiovascular · 99d