IR PRO 250— 510(k) K061080

Substantially Equivalent

Lhasa Oms, Inc.

FDA 510(k) clearance K061080 for IR PRO 250, Substantially Equivalent on 2006-06-14. Applicant: Lhasa Oms, Inc..

Clearance details

Applicant: Lhasa Oms, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2006-04-18
Decision date: 2006-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weymouth, MA, 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.