Esteya— 510(k) K213942

Substantially Equivalent

Nucletron B.V.

FDA 510(k) clearance K213942 for Esteya, Substantially Equivalent on 2022-01-11. Applicant: Nucletron B.V..

Clearance details

Applicant: Nucletron B.V.
Product code: Code JAD
Advisory panel: Radiology
Date received: 2021-12-17
Decision date: 2022-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Veenendaal, NL

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