Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A Software
FDA 510(k) K022740 · Datex-Ohmeda
510(k) numberK022740
Submission
- Device name
- Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A Software
- Applicant
- Datex-Ohmeda
Needham, MA, US - Received
- August 19, 2002
- Decision date
- November 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLD – Monitor, St Segment With Alarm
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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|---|---|---|---|
| K101602 | Vital Signs MonitorMLD · Special | Criticare Systems, Inc. | 09/01/2010SE |
| K080461 | Star ST and Arrhythmia Software, Release J.0MLD · Special | Philips Medical Systems | 03/13/2008SE |
| K012837 | Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and AccessoriesMLD · Special | Datex-Ohmeda | 09/14/2001SE |
| K002105 | Siemens Infinity SC 6002XL Enhanced with ST Segment AnalysisMLD · Traditional | Siemens Medical Solutions USA, Inc. | 12/05/2000SE |
| K992323 | Datex-Ohmeda Cardiocap 5, F-Mx, F-Mxg and AccessoriesMLD · Traditional | Datex-Ohmeda, Inc. | 11/01/1999SE |
| K982104 | Escort-Link Central Station Monitor Model 20500MLD · Special | Medical Data Electronics | 11/25/1998SE |
| K974492 | Siemens SC6000/SC6000P Bedside Monitoring System Enhanced with ST Segment AnalysisMLD · Traditional | Siemens Medical Solutions USA, Inc. | 02/26/1998SE |
| K972121 | Acuity Central StationMLD · Traditional | Protocol Systems, Inc. | 11/07/1997SE |
| K953175 | AS/3 Estpr ModuleMLD · Traditional | Datex Division Instrumentarium Corp. | 02/06/1997SE |
| K960272 | Eagle 3000/3100 Patient MonitorMLD · Traditional | Marquette Electronics, Inc. | 10/02/1996SE |
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Questions and answers
When was Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A Software cleared by the FDA?
Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A Software (K022740) received a 510(k) decision of Substantially Equivalent on November 14, 2002, 87 days after the submission was received.
What is the product code of K022740?
The FDA product code is MLD – Monitor, St Segment With Alarm, a Class II (moderate risk) device regulated under 21 CFR 870.1025.