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FDA 510(k)

THE TELESCAN C.A.R.E. SYSTEM

K-Number: K871587 · 1987-08-12

ApplicantTelescan Medical Systems
Decision Date1987-08-12
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE TELESCAN C.A.R.E. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Telescan Medical Systems. It received FDA 510(k) clearance on 1987-08-12 under 510(k) number K871587. 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 THE TELESCAN C.A.R.E. SYSTEM?

THE TELESCAN C.A.R.E. SYSTEM is a medical device that received FDA 510(k) clearance on 1987-08-12. The listed applicant is Telescan Medical Systems. The 510(k) number is K871587.

When did THE TELESCAN C.A.R.E. SYSTEM receive FDA 510(k) clearance?

THE TELESCAN C.A.R.E. SYSTEM received FDA 510(k) clearance on 1987-08-12, under 510(k) number K871587.

Who is the listed applicant for THE TELESCAN C.A.R.E. SYSTEM?

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

What is the FDA product code for THE TELESCAN C.A.R.E. SYSTEM?

The FDA product code for THE TELESCAN C.A.R.E. 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 Telescan Medical Systems 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.

K942586CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)K924187INSTANT MEMORY 2000K883358TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CMK820276TELESCAN T-30

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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