The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Disposable Mri Kit W/check Valve Modelsqk 65v, Medrad Mri Integral T With Check Valve Model Sit 96v.
| Device ID | K980417 |
| 510k Number | K980417 |
| Device Name: | MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Sandra Pavlovic |
| Correspondent | Sandra Pavlovic MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-03 |
| Decision Date | 1998-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10616258007813 | K980417 | 000 |
| 40616258010005 | K980417 | 000 |
| 40616258021834 | K980417 | 000 |
| 40616258021667 | K980417 | 000 |
| 40616258021582 | K980417 | 000 |
| 40616258021568 | K980417 | 000 |
| 40616258021131 | K980417 | 000 |
| 40616258021124 | K980417 | 000 |
| 00616258021119 | K980417 | 000 |
| 40616258021100 | K980417 | 000 |
| 40616258024996 | K980417 | 000 |
| 40616258024484 | K980417 | 000 |
| 40616258010036 | K980417 | 000 |
| 40616258010111 | K980417 | 000 |
| 00616258007779 | K980417 | 000 |
| 10616258007387 | K980417 | 000 |
| 00616258007342 | K980417 | 000 |
| 10616258007295 | K980417 | 000 |
| 10616258007271 | K980417 | 000 |
| 10616258007011 | K980417 | 000 |
| 10616258005673 | K980417 | 000 |
| 10616258005529 | K980417 | 000 |
| 10616258005512 | K980417 | 000 |
| 10616258005475 | K980417 | 000 |
| 00616258005447 | K980417 | 000 |
| 40616258024309 | K980417 | 000 |