CASS SYSTEM— 510(k) K894263

Substantially Equivalent

Medical Instrumentation & Diagnostics Corp.(Midco)

FDA 510(k) clearance K894263 for CASS SYSTEM, Substantially Equivalent on 1989-09-01. Applicant: Medical Instrumentation & Diagnostics Corp.(Midco).

Clearance details

Applicant: Medical Instrumentation & Diagnostics Corp.(Midco)
Product code: Code HAW
Advisory panel: Neurology
Date received: 1989-06-20
Decision date: 1989-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albuquerque, NM, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.