FDA 510(k) K233737, ulricheasyINJECT Max 2M and Max 3 (XD 10140, XD 10150, XD 10180), by Ulrich GmbH & Co. KG

510(K) Number: K233737
Device Name: ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
Manufacturer: Ulrich GmbH & Co. KG
Device Classification Name: Injector, Contrast Medium, Automatic
Regulation Number: 870.1650
Classification Product Code: IZQ
Date Received: 11/22/2023
Decision Date: 04/19/2024
Regulation Medical Specialty: Cardiovascular

Total Pages: 8,573
Fully Redacted Pages: 5,988
Content Pages: 2,585