DMI PC HOLTER SCANNER— 510(k) K894285

Substantially Equivalent

Diagnostic Medical Instruments

FDA 510(k) clearance K894285 for DMI PC HOLTER SCANNER, Substantially Equivalent on 1989-09-26. Applicant: Diagnostic Medical Instruments.

Clearance details

Applicant: Diagnostic Medical Instruments
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1989-06-23
Decision date: 1989-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Syracuse, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.