LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM— 510(k) K132016

Substantially Equivalent

Texas Applied Biomedical Services, Inc.

FDA 510(k) clearance K132016 for LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM, Substantially Equivalent on 2014-06-02. Applicant: Texas Applied Biomedical Services, Inc..

Clearance details

Applicant: Texas Applied Biomedical Services, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2013-07-01
Decision date: 2014-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.