INTRACRANIAL PRESSURING MONITORING SYST.— 510(k) K802100

Substantially Equivalent

Pudenz-Schulte Medical Research Corp.

FDA 510(k) clearance K802100 for INTRACRANIAL PRESSURING MONITORING SYST., Substantially Equivalent on 1980-09-16. Applicant: Pudenz-Schulte Medical Research Corp..

Clearance details

Applicant: Pudenz-Schulte Medical Research Corp.
Product code: Code GWM
Advisory panel: Neurology
Date received: 1980-09-03
Decision date: 1980-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.