Medical Device Manufacturer · US , Madison , WI

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

60 submissions · 60 cleared · Since 1998

60

Total

60

Cleared

0

Denied

FDA 510(k) cleared devices by Datex-Ohmeda, Inc. Cardiovascular ✕

7 devices

1-7 of 7

Cleared Dec 04, 2003

POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR

Cardiovascular · 240d

Cleared Jun 06, 2003

AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL...

Cardiovascular · 29d

Cleared Oct 05, 2000

S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08

Cardiovascular · 55d

Cleared Sep 06, 2000

S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE

Cardiovascular · 51d

Cleared Jul 13, 2000

DATEX-OHMEDA NETWORK AND CENTRAL

Cardiovascular · 136d

Cleared Apr 13, 2000

DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)

Cardiovascular · 171d

Cleared Nov 01, 1999

DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES

Cardiovascular · 112d