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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Contrast Medium, Automatic
510(k) Number K252281
Device Name ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
Applicant
Ulrich GmbH & Co. KG
Buchbrunnenweg 12
Ulm,  DE 89081
Applicant Contact Erdmann Sven
Correspondent
MethodSense, Inc.
1 Copley Pkwy. Suite 130
Morrisville,  NC  27560
Correspondent Contact Rita King
Regulation Number870.1650
Classification Product Code
IZQ  
Date Received07/22/2025
Decision Date 11/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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