Universal DR 1748— 510(k) K214030

Substantially Equivalent

Konica Minolta Healthcare Americas, Inc.

FDA 510(k) clearance K214030 for Universal DR 1748, Substantially Equivalent on 2022-01-21. Applicant: Konica Minolta Healthcare Americas, Inc.. Device class: 2.

Clearance details

Applicant
Konica Minolta Healthcare Americas, Inc.
Product code
Code MQB
Device class
Class 2
Regulation
21 CFR 892.1680
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Garner, NC, US
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