LUMINEB I— 510(k) K884722

Substantially Equivalent

Lumiscope Co., Inc.

FDA 510(k) clearance K884722 for LUMINEB I, Substantially Equivalent on 1989-02-03. Applicant: Lumiscope Co., Inc..

Clearance details

Applicant: Lumiscope Co., Inc.
Product code: Code BTI
Advisory panel: Anesthesiology
Date received: 1988-11-10
Decision date: 1989-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

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Adverse events under product code BTI

product code BTI

Death: 25
Malfunction: 1,168
Total: 1,193

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.