ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)— 510(k) K233737
Substantially EquivalentUlrich GmbH & Co. KG
FDA 510(k) clearance K233737 for ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180), Substantially Equivalent on 2024-04-19. Applicant: Ulrich GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Ulrich GmbH & Co. KG
- Product code
- Code IZQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ulm, DE
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More clearances from Ulrich GmbH & Co. KG
view allAdverse events under product code IZQ
product code IZQ- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.