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FDA 510(k)

EARLYSENSE CENTRAL DISPLAY SYSTEM

K-Number: K121885 · 2012-09-10

ApplicantEarlysense, Ltd.
Decision Date2012-09-10
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EARLYSENSE CENTRAL DISPLAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Earlysense, Ltd.. It received FDA 510(k) clearance on 2012-09-10 under 510(k) number K121885. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EARLYSENSE CENTRAL DISPLAY SYSTEM?

EARLYSENSE CENTRAL DISPLAY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-10. The listed applicant is Earlysense, Ltd.. The 510(k) number is K121885.

When did EARLYSENSE CENTRAL DISPLAY SYSTEM receive FDA 510(k) clearance?

EARLYSENSE CENTRAL DISPLAY SYSTEM received FDA 510(k) clearance on 2012-09-10, under 510(k) number K121885.

Who is the listed applicant for EARLYSENSE CENTRAL DISPLAY SYSTEM?

The FDA 510(k) record lists Earlysense, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EARLYSENSE CENTRAL DISPLAY SYSTEM?

The FDA product code for EARLYSENSE CENTRAL DISPLAY SYSTEM is MSX.

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Other records listing Earlysense, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171836EarlySense Bed Sensing UnitK152911EarlySense Insight SytemK131379EARLYSENSEK120465EARLYSENSE (EVERON) SYSTEMK110521EVERON CENTRAL DISPLAY STATION (CDS)K100376EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0

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Related Devices (Code: MSX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261287Digistat CareAscom Ums Srl UnipersonaleK260211Dashboard (P007000)Hill-Rom, Inc.K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbHK243270TigerConnect Alarm ManagementTigerconnectK242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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