EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825— 510(k) K031571
Substantially EquivalentE-Z-Em, Inc.
FDA 510(k) clearance K031571 for EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825, Substantially Equivalent on 2003-06-19. Applicant: E-Z-Em, Inc.. Device class: 2.
Clearance details
- Applicant
- E-Z-Em, Inc.
- 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
- Special
- Location
- Westbury, NY, US
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More clearances from E-Z-Em, Inc.
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.