IMPACT, MODEL 303— 510(k) K820337

Name: FDA 510(k) clearance K820337
Creator: U.S. Food and Drug Administration
Published: 1982-03-02

Substantially Equivalent

Impact Instrumentation, Inc.

FDA 510(k) clearance K820337 for IMPACT, MODEL 303, Substantially Equivalent on 1982-03-02. Applicant: Impact Instrumentation, Inc.. Device class: 2.

Clearance details

Applicant: Impact Instrumentation, Inc.
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1982-02-08
Decision date: 1982-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.