SETMA VHT— 510(k) K853163

Substantially Equivalent

Setma, Inc.

FDA 510(k) clearance K853163 for SETMA VHT, Substantially Equivalent on 1985-11-05. Applicant: Setma, Inc..

Clearance details

Applicant: Setma, Inc.
Product code: Code ILJ
Advisory panel: Physical Medicine
Date received: 1985-07-30
Decision date: 1985-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whitehouse, NJ, US

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Adverse events under product code ILJ

product code ILJ

Death: 4
Total: 4

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.