510(k) K241850

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) by Ulrich GmbH & Co. KG — Product Code IZQ

K241850 is an FDA 510(k) premarket notification submitted by Ulrich GmbH & Co. KG for the device "ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)". The FDA issued a decision of Substantially Equivalent on August 26, 2024. The device falls under product code IZQ (Injector, Contrast Medium, Automatic), a Class II device regulated under 21 CFR 870.1650. Ulrich GmbH & Co. KG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2024
Date Received
June 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Contrast Medium, Automatic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type