Blue Phantom PT— 510(k) K191821

Substantially Equivalent

Iba Dosimetry GmbH

FDA 510(k) clearance K191821 for Blue Phantom PT, Substantially Equivalent on 2020-01-23. Applicant: Iba Dosimetry GmbH. Device class: 2.

Clearance details

Applicant: Iba Dosimetry GmbH
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2019-07-08
Decision date: 2020-01-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Schwarzenbruck, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.