The following data is part of a premarket notification filed by Neoprobe Corp. with the FDA for Neoprobe Portable Radioscope Detector.
| Device ID | K915279 |
| 510k Number | K915279 |
| Device Name: | NEOPROBE PORTABLE RADIOSCOPE DETECTOR |
| Classification | Probe, Uptake, Nuclear |
| Applicant | NEOPROBE CORP. 855 WEST FIFTH AVE. Columbus, OH 43212 |
| Contact | Roger P.kaminski |
| Correspondent | Roger P.kaminski NEOPROBE CORP. 855 WEST FIFTH AVE. Columbus, OH 43212 |
| Product Code | IZD |
| CFR Regulation Number | 892.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-25 |
| Decision Date | 1992-06-10 |