CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM— 510(k) K133661

Name: FDA 510(k) clearance K133661
Creator: U.S. Food and Drug Administration
Published: 2014-06-13

Substantially Equivalent

Earlysense, Ltd.

FDA 510(k) clearance K133661 for CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM, Substantially Equivalent on 2014-06-13. Applicant: Earlysense, Ltd.. Device class: 2.

Clearance details

Applicant: Earlysense, Ltd.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2013-11-29
Decision date: 2014-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramat-Gan, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZQ

view all

K253274 — BedDot (G1)2026-06-25
K251326 — Respiration Rate algorithm2026-06-11
K250093 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)2025-09-26
K250934 — Respiree Cardio- Respiratory Monitor System2025-08-05
K243183 — RTMsense Respiratory Monitoring System2025-06-27

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
K131379 — EARLYSENSE2013-12-18
K121885 — EARLYSENSE CENTRAL DISPLAY SYSTEM2012-09-10

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