ICP MONITOR MODEL 1000— 510(k) K844566

Substantially Equivalent

Advanced Ultrasonic Testing & Research Corp.

FDA 510(k) clearance K844566 for ICP MONITOR MODEL 1000, Substantially Equivalent on 1985-08-16. Applicant: Advanced Ultrasonic Testing & Research Corp..

Clearance details

Applicant: Advanced Ultrasonic Testing & Research Corp.
Product code: Code GWM
Advisory panel: Neurology
Date received: 1984-11-23
Decision date: 1985-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

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Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

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.