MINI-HOLTER, MODEL 2000— 510(k) K862526

Substantially Equivalent

Holter Recorders

FDA 510(k) clearance K862526 for MINI-HOLTER, MODEL 2000, Substantially Equivalent on 1986-08-25. Applicant: Holter Recorders.

Clearance details

Applicant: Holter Recorders
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 1986-07-02
Decision date: 1986-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Corona, 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.