MD VISION SYSTEM— 510(k) K101474

Substantially Equivalent

Perkins Healthcare Technologies

FDA 510(k) clearance K101474 for MD VISION SYSTEM, Substantially Equivalent on 2010-07-02. Applicant: Perkins Healthcare Technologies.

Clearance details

Applicant: Perkins Healthcare Technologies
Product code: Code DXJ
Advisory panel: Cardiovascular
Date received: 2010-05-28
Decision date: 2010-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

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.