EarlySense Central Display Station (CDS)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151006 FDA 510(k)
- FDA Product Code
- MSX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EarlySense Central Display Station (CDS) is a software application installed on standard off-the-shelf PC hardware that communicates via TCP/IP with multiple EarlySense bedside monitoring units. It displays patients' measurements and allows for individual settings configuration.
The device is supplied as part of a system that includes EarlySense developed application software. It is used in conjunction with bedside monitoring units and requires regulatory-approved central monitoring stations. The device is FDA 510(k) cleared with product code MSX and is classified as a Class II device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EarlySense Central Display Station (CDS) by EARLYSENSE LTD. | FDA 510 ..., EarlySense Central Display Station (CDS) User Guide - Manuals+, EarlySense Central Display Station (CDS) (K151006) — FDA 510 (k ..., INSIGHT EarlySense InSight System User Manual - FCC ID 2AQ32-INSIGHT
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151006 | Class II | Active |
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Manufacturer
- Manufacturer
- Earlysense, Ltd.
Sources (1)
- FDA 510(k) K151006 24 fields · synced Sep 22, 2026