The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Spectris Mr Injector.
| Device ID | K935668 |
| 510k Number | K935668 |
| Device Name: | MEDRAD SPECTRIS MR INJECTOR |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. P.O. BOX 780, MEDRAD DR. OFF RTE 910 Indianola, PA 15051 |
| Contact | Jan E Burtick |
| Correspondent | Jan E Burtick MEDRAD, INC. P.O. BOX 780, MEDRAD DR. OFF RTE 910 Indianola, PA 15051 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-26 |
| Decision Date | 1995-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258010533 | K935668 | 000 |