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FDA 510(k)

CARE 5000 SYSTEM

K-Number: K894858 · 1989-10-12

ApplicantCare Systems, Inc.
Decision Date1989-10-12
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARE 5000 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Care Systems, Inc.. It received FDA 510(k) clearance on 1989-10-12 under 510(k) number K894858. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARE 5000 SYSTEM?

CARE 5000 SYSTEM is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Care Systems, Inc.. The 510(k) number is K894858.

When did CARE 5000 SYSTEM receive FDA 510(k) clearance?

CARE 5000 SYSTEM received FDA 510(k) clearance on 1989-10-12, under 510(k) number K894858.

Who is the listed applicant for CARE 5000 SYSTEM?

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

What is the FDA product code for CARE 5000 SYSTEM?

The FDA product code for CARE 5000 SYSTEM is DSI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Care Systems, Inc. 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.

K910109CARDIOSWISS CM-8K874844CARE TELSTAT MODELS: MP 5010 AND MP 5020

Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

Official Source

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

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