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FDA 510(k), K233737, ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
FDA 510(k), K233737, ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
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$1,234.91 USD
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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
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
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