E-Z EM PERCUPUMP 2001 CT INJECTOR— 510(k) K011160
Substantially EquivalentE-Z-Em, Inc.
FDA 510(k) clearance K011160 for E-Z EM PERCUPUMP 2001 CT INJECTOR, Substantially Equivalent on 2001-05-16. Applicant: E-Z-Em, Inc.. Device class: 2.
Clearance details
- Applicant
- E-Z-Em, Inc.
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Westbury, NY, US
Recent devices under product code JAK
view allMore clearances from E-Z-Em, Inc.
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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.