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

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.

Clearance details

Applicant: Telescan Medical Systems
Product code: Code DSH
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 ↗

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.