UNIEXPERT 2 PLUS— 510(k) K200944

Substantially Equivalent

Adani

FDA 510(k) clearance K200944 for UNIEXPERT 2 PLUS, Substantially Equivalent on 2020-05-26. Applicant: Adani.

Clearance details

Applicant: Adani
Product code: Code KPR
Advisory panel: Radiology
Date received: 2020-04-08
Decision date: 2020-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minsk, BY

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.