The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Empowermr Injector System, Model 9730.
| Device ID | K062449 |
| 510k Number | K062449 |
| Device Name: | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 |
| Classification | Injector, Contrast Medium, Automatic |
| Applicant | E-Z-EM, INC. 750 SUMMA AVE. Westbury, NY 11590 |
| Contact | Robert Williams |
| Correspondent | Robert Williams E-Z-EM, INC. 750 SUMMA AVE. Westbury, NY 11590 |
| Product Code | IZQ |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-22 |
| Decision Date | 2007-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 47630039300751 | K062449 | 000 |
| 37630039300990 | K062449 | 000 |
| 37630039301010 | K062449 | 000 |
| 37630039301034 | K062449 | 000 |
| 47630039300973 | K062449 | 000 |
| 37630039300297 | K062449 | 000 |
| 37630039300365 | K062449 | 000 |
| 37630039300372 | K062449 | 000 |
| 37630039300389 | K062449 | 000 |
| 37630039300396 | K062449 | 000 |
| 37630039300785 | K062449 | 000 |
| 37630039300860 | K062449 | 000 |
| 37630039300402 | K062449 | 000 |
| 37630039300419 | K062449 | 000 |
| 37630039300730 | K062449 | 000 |
| 17630039301627 | K062449 | 000 |