The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Modification To Empower Ct/cta Injector System, Models 9800/9900 Product Series.
| Device ID | K071378 |
| 510k Number | K071378 |
| Device Name: | MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | E-Z-EM, INC. 750 SUMMA AVE. Westbury, NY 11590 |
| Contact | Steven Hartman |
| Correspondent | Steven Hartman E-Z-EM, INC. 750 SUMMA AVE. Westbury, NY 11590 |
| Product Code | JAK |
| Subsequent Product Code | DSB |
| Subsequent Product Code | IZQ |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-17 |
| Decision Date | 2007-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 47630039302014 | K071378 | 000 |
| 47630039301949 | K071378 | 000 |