ILLUMINATOR— 510(k) K954787

Name: FDA 510(k) clearance K954787
Creator: U.S. Food and Drug Administration
Published: 1996-01-31

Substantially Equivalent

Hospitak, Inc.

FDA 510(k) clearance K954787 for ILLUMINATOR, Substantially Equivalent on 1996-01-31. Applicant: Hospitak, Inc.. Device class: 1.

Clearance details

Applicant: Hospitak, Inc.
Product code: Code CCW
Device class: Class 1
Regulation: 21 CFR 868.5540
Advisory panel: Anesthesiology
Date received: 1995-10-18
Decision date: 1996-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

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.