UNFORS PATIENT SKIN DOSIMETER (PSD)— 510(k) K042698

Substantially Equivalent

Unfors, Inc.

FDA 510(k) clearance K042698 for UNFORS PATIENT SKIN DOSIMETER (PSD), Substantially Equivalent on 2004-10-22. Applicant: Unfors, Inc..

Clearance details

Applicant: Unfors, Inc.
Product code: Code JAA
Advisory panel: Radiology
Date received: 2004-09-30
Decision date: 2004-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Milford, CT, US

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.