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FDA 510(k)

FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM)

K-Number: K871944 · 1987-06-24

ApplicantFuturecare Systems, Inc.
Decision Date1987-06-24
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Futurecare Systems, Inc.. It received FDA 510(k) clearance on 1987-06-24 under 510(k) number K871944. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM)?

FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM) is a medical device that received FDA 510(k) clearance on 1987-06-24. The listed applicant is Futurecare Systems, Inc.. The 510(k) number is K871944.

When did FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM) receive FDA 510(k) clearance?

FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM) received FDA 510(k) clearance on 1987-06-24, under 510(k) number K871944.

Who is the listed applicant for FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM)?

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

What is the FDA product code for FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM)?

The FDA product code for FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM) is DSH.

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 Futurecare 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.

K903512FUTURECARE CARELYNK IV SYSTEMK863716RNET SYSTEM, IV RECEIVING TERMINAL, TRANSMITTER

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens 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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