The following data is part of a premarket notification filed by Neoprobe Corp. with the FDA for Neoprobe Model 1500 Portable Radioisotope Detector And Accessories.
| Device ID | K971167 |
| 510k Number | K971167 |
| Device Name: | NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES |
| Classification | Probe, Uptake, Nuclear |
| Applicant | NEOPROBE CORP. 425 METRO PLACE NORTH, STE. 300 Dublin, OH 43017 |
| Contact | Susan D Tiedy-stevenson |
| Correspondent | Susan D Tiedy-stevenson NEOPROBE CORP. 425 METRO PLACE NORTH, STE. 300 Dublin, OH 43017 |
| Product Code | IZD |
| CFR Regulation Number | 892.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-31 |
| Decision Date | 1997-06-26 |
| Summary: | summary |