The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Prostate Probe Surface Coil, Catalog #bpx-15.
| Device ID | K901888 |
| 510k Number | K901888 |
| Device Name: | PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Contact | Francis X Dobscha |
| Correspondent | Francis X Dobscha MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-26 |
| Decision Date | 1990-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10616258009237 | K901888 | 000 |
| 10616258009213 | K901888 | 000 |
| 10616258009206 | K901888 | 000 |
| 10616258009190 | K901888 | 000 |
| 10850011472160 | K901888 | 000 |
| 00850011472149 | K901888 | 000 |
| 10850011472122 | K901888 | 000 |