Hybrid Viewer (00859873006189)— 510(k) K241364

Substantially Equivalent

Hermes Medical Solutions AB

FDA 510(k) clearance K241364 for Hybrid Viewer (00859873006189), Substantially Equivalent on 2024-11-08. Applicant: Hermes Medical Solutions AB. Device class: 2.

Clearance details

Applicant
Hermes Medical Solutions AB
Product code
Code KPS
Device class
Class 2
Regulation
21 CFR 892.1200
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stockholm, SE
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