FIRARD II/ TDP LAMP— 510(k) K960036

Substantially Equivalent

Helio Medical Supplies, Inc.

FDA 510(k) clearance K960036 for FIRARD II/ TDP LAMP, Substantially Equivalent on 1996-06-06. Applicant: Helio Medical Supplies, Inc..

Clearance details

Applicant: Helio Medical Supplies, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 1996-01-02
Decision date: 1996-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

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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.