Medical Device Manufacturer · US , Tewksbury , MA

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

9 submissions · 9 cleared · Since 1998

Total

Cleared

Denied

Datex-Engstrom, Inc. has 9 FDA 510(k) cleared medical devices. Based in Tewksbury, US.

Historical record: 9 cleared submissions from 1998 to 1998. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Datex-Engstrom, Inc. Filter by specialty or product code using the sidebar.

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

9 devices

1-9 of 9

Cleared Dec 23, 1998

TRIP TONOMETRY CATHETER, 16F

K983366 · KNT

Gastroenterology & Urology · 90d

Cleared Dec 22, 1998

CS/3 COMPACT AIRWAY MODULE, M-COVX

K982091 · MHX

Cardiovascular · 190d

Cleared Nov 03, 1998

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

K981378 · DRT

Cardiovascular · 201d

Cleared Oct 30, 1998

AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)

K973985 · BSZ

Anesthesiology · 375d

Cleared Jun 30, 1998

MRI COMPATIBLE MONITOR AND ACCESSORIES

K980362 · DPS

Cardiovascular · 152d

Cleared Jun 02, 1998

CS/3(TM) MONITORS*

K974792 · DSI

Cardiovascular · 162d

Cleared May 01, 1998

TRIP TONOMETRY CATHETER, 18F

K980384 · CCK

Anesthesiology · 88d

Cleared Apr 23, 1998

CS/3 ARRHYTHMIA WORKSTATION

K974747 · DSI

Cardiovascular · 125d

Cleared Feb 06, 1998

DATEX-ENGSTROM NETWORK

K974101 · MSX

Cardiovascular · 99d

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

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