The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Envision Ct Injector System.
| Device ID | K993728 |
| 510k Number | K993728 |
| Device Name: | MEDRAD ENVISION CT INJECTOR SYSTEM |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Jan E Dobscha |
| Correspondent | Jan E Dobscha MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-04 |
| Decision Date | 1999-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258010519 | K993728 | 000 |
| 00616258010472 | K993728 | 000 |
| 00616258010410 | K993728 | 000 |
| 00616258010403 | K993728 | 000 |
| 00616258010397 | K993728 | 000 |