The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Flex Interface Device.
| Device ID | K971380 |
| 510k Number | K971380 |
| Device Name: | MEDRAD FLEX INTERFACE DEVICE |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Rodney J Rylands |
| Correspondent | Rodney J Rylands 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 | 1997-04-14 |
| Decision Date | 1997-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258009056 | K971380 | 000 |
| 00616258009049 | K971380 | 000 |