MLT-2— 510(k) K935981

Substantially Equivalent

Med Labs, Inc.

FDA 510(k) clearance K935981 for MLT-2, Substantially Equivalent on 1994-02-17. Applicant: Med Labs, Inc..

Clearance details

Applicant: Med Labs, Inc.
Product code: Code ILQ
Advisory panel: Physical Medicine
Date received: 1993-12-14
Decision date: 1994-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

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Adverse events under product code ILQ

product code ILQ

Death: 4
Malfunction: 477
Total: 481

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.