Spacelabs Medical Clinical Event Interface, Model 91847
FDA 510(k) K062278 · Spacelabs Medical, Inc.
510(k) numberK062278
Submission
- Device name
- Spacelabs Medical Clinical Event Interface, Model 91847
- Applicant
- Spacelabs Medical, Inc.
Issaquah, WA, US - Received
- August 7, 2006
- Decision date
- September 19, 2006
- 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
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| 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 |
|---|---|---|
| K120616 | Spacelabs Healthcare Qube Compact Monitor (91390MHX · Special | 03/29/2012SE |
| K112962 | Spacelabs Healthcare Xprezzon Beside MONITOR(9913930)MHX · Special | 11/02/2011SE |
| K102422 | Spacelabs Medical Patient MonitorsMHX · Special | 12/07/2010SE |
| K093501 | Elance Vital Signs Monitor and Elance Central StationMHX · Special | 11/24/2009SE |
| K082045 | Modification to Mcare 300 Vital Signs Monitor, Model 91220MHX · Special | 08/01/2008SE |
| K063490 | Spacelabs Medical Full Disclosure System, Model 91810DQK · Traditional | 03/15/2007SE |
| K062095 | Mcare 300 Vital Signs Monitor, Model 91220MHX · Abbreviated | 09/29/2006SE |
| K060900 | Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and Accessories…OLW · Traditional | 06/23/2006SE |
| K053599 | Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesCBR · Special | 04/19/2006SE |
| K050605 | Spacelabs Medical Multiparameter Module 91496DSI · Special | 05/03/2005SE |
Questions and answers
When was Spacelabs Medical Clinical Event Interface, Model 91847 cleared by the FDA?
Spacelabs Medical Clinical Event Interface, Model 91847 (K062278) received a 510(k) decision of Substantially Equivalent on September 19, 2006, 43 days after the submission was received.
What is the product code of K062278?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.