Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03 Software
FDA 510(k) K033078 · Datex-Ohmeda
510(k) numberK033078
Submission
- Device name
- Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03 Software
- Applicant
- Datex-Ohmeda
Needham, MA, US - Received
- September 29, 2003
- Decision date
- October 29, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code MSX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261287 | Digistat CareMSX · Traditional | Ascom Ums Srl Unipersonale | 09/12/2026SE |
| K260211 | Dashboard (P007000)MSX · Traditional | Hill-Rom, Inc. | 08/13/2026SE |
| K261367 | Corsano CardioWatch 287-2 SystemMSX · Traditional | Corsano Health B.V. | 07/26/2026SE |
| K253654 | IntelliVue Measurement Rack 6000 (867317)MSX · Traditional | Philips Medizin Systeme Böblingen GmbH | 03/30/2026SE |
| K243270 | TigerConnect Alarm ManagementMSX · Traditional | Tigerconnect | 09/30/2025SE |
| K242728 | BeneVision Central Monitoring SystemMSX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 07/31/2025SE |
| K242750 | Central StationMSX · Traditional | Nihon Kohden Digital Health Solutions, LLC | 06/05/2025SE |
| K242842 | ANNE View, Central HubMSX · Traditional | Sibel Health, Inc. | 01/08/2025SE |
| K241397 | HinscopeMSX · Traditional | Hinlab Sas | 11/14/2024SE |
| K233834 | Infinity Gateway SuiteMSX · Traditional | Draeger Medical Systems, Inc. | 07/12/2024SE |
More from Draeger Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254036 | Novii+ Wireless Patch SystemHGM · Traditional | 08/10/2026SE |
| K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | 07/28/2026SE |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | 10/22/2025SE |
| K231964 | Novii+ Wireless Patch SystemHGM · Traditional | 12/08/2023SE |
| K213867 | Carestation 750/750cBSZ · Traditional | 03/28/2023SE |
| K213553 | Giraffe Incubator Carestation CS1FMZ · Traditional | 03/02/2022SE |
| K213551 | Giraffe Omnibed Carestation CS1FMT · Traditional | 03/02/2022SE |
| K210384 | Carescape R860CBK · Traditional | 11/04/2021SE |
| K172702 | Tec 820, Tec 850CAD · Traditional | 01/04/2018SE |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…BSZ · Traditional | 11/03/2017SE |
Questions and answers
When was Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03 Software cleared by the FDA?
Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03 Software (K033078) received a 510(k) decision of Substantially Equivalent on October 29, 2003, 30 days after the submission was received.
What is the product code of K033078?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.