EarlySense Central Display Station (CDS)
FDA 510(k) K151006 · Earlysense, Ltd.
510(k) numberK151006
Submission
- Device name
- EarlySense Central Display Station (CDS)
- Applicant
- Earlysense, Ltd.
Ramat Gan, IL - Received
- April 15, 2015
- Decision date
- August 31, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K171836 | EarlySense Bed Sensing UnitBZQ · Traditional | 01/04/2018SE |
| K152911 | EarlySense Insight SytemBZQ · Traditional | 05/06/2016SE |
| K133661 | Chair Sensing Unit for Earlysense SystemBZQ · Traditional | 06/13/2014SE |
| K131379 | EarlysenseBZQ · Traditional | 12/18/2013SE |
| K121885 | Earlysense Central Display SystemMSX · Special | 09/10/2012SE |
| K120465 | Earlysense (Everon) SystemBZQ · Traditional | 06/08/2012SE |
| K110521 | Everon Central Display Station (CDS)MSX · Special | 04/19/2011SE |
| K100376 | Everon Central Display Station - CDS, Model Version 1.0.0MSX · Traditional | 08/06/2010SE |
| K092062 | Everon 1.0BZQ · Traditional | 05/24/2010SE |
| K082465 | EveronBZQ · Traditional | 03/25/2009SE |
Questions and answers
When was EarlySense Central Display Station (CDS) cleared by the FDA?
EarlySense Central Display Station (CDS) (K151006) received a 510(k) decision of Substantially Equivalent on August 31, 2015, 138 days after the submission was received.
What is the product code of K151006?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.