The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for E-z Em Percupump 2001 Ct Injector.
| Device ID | K011160 |
| 510k Number | K011160 |
| Device Name: | E-Z EM PERCUPUMP 2001 CT INJECTOR |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Bob Williams |
| Correspondent | Bob Williams E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-16 |
| Decision Date | 2001-05-16 |