THE TELESCAN C.A.R.E. SYSTEM— 510(k) K871587

Name: FDA 510(k) clearance K871587
Creator: U.S. Food and Drug Administration
Published: 1987-08-12

Substantially Equivalent

Telescan Medical Systems

FDA 510(k) clearance K871587 for THE TELESCAN C.A.R.E. SYSTEM, Substantially Equivalent on 1987-08-12. Applicant: Telescan Medical Systems. Device class: 2.

Clearance details

Applicant: Telescan Medical Systems
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1987-04-24
Decision date: 1987-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auburn, CA, US

Download summary PDF View on FDA.gov ↗

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K243650 — Zio® monitor (DFG0001)2025-08-15
K243603 — AeviceMD2025-05-05

More clearances from Telescan Medical Systems

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K942586 — CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)1995-05-10
K924187 — INSTANT MEMORY 20001993-06-16
K883358 — TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM1988-10-13
K820276 — TELESCAN T-301982-02-12

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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