EARLYSENSE CENTRAL DISPLAY SYSTEM— 510(k) K121885

Name: FDA 510(k) clearance K121885
Creator: U.S. Food and Drug Administration
Published: 2012-09-10

Substantially Equivalent

Earlysense, Ltd.

FDA 510(k) clearance K121885 for EARLYSENSE CENTRAL DISPLAY SYSTEM, Substantially Equivalent on 2012-09-10. Applicant: Earlysense, Ltd.. Device class: 2.

Clearance details

Applicant: Earlysense, Ltd.
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2012-06-28
Decision date: 2012-09-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Ramat-Gan, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code MSX

view all

K260211 — Dashboard (P007000)2026-08-13
K261367 — Corsano CardioWatch 287-2 System2026-07-26
K253654 — IntelliVue Measurement Rack 6000 (867317)2026-03-30
K243270 — TigerConnect Alarm Management2025-09-30
K242728 — BeneVision Central Monitoring System2025-07-31

More clearances from Earlysense, Ltd.

view all

K171836 — EarlySense Bed Sensing Unit2018-01-04
K152911 — EarlySense Insight Sytem2016-05-06
K151006 — EarlySense Central Display Station (CDS)2015-08-31
K133661 — CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM2014-06-13
K131379 — EARLYSENSE2013-12-18

Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.