HALO— 510(k) K211788

Substantially Equivalent

Nicolab B.V.

FDA 510(k) clearance K211788 for HALO, Substantially Equivalent on 2021-07-08. Applicant: Nicolab B.V..

Clearance details

Applicant: Nicolab B.V.
Product code: Code QAS
Advisory panel: Radiology
Date received: 2021-06-09
Decision date: 2021-07-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Amsterdam, NL

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