VeriSuite— 510(k) K181789

Clearance details

Applicant

Medcom GmbH

Product code

Code LHN

Device class

Class 2

Regulation

21 CFR 892.5050

Advisory panel

Radiology

Date received

2018-07-05

Decision date

2018-09-21

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Darmstadt, DE

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