The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Nt2000.
| Device ID | K972244 |
| 510k Number | K972244 |
| Device Name: | NT2000 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIO-MEDICAL RESEARCH, LTD. 14900 SWEITZER LN. SUITE 200 Laurel, MD 20707 |
| Contact | Greg Shipp |
| Correspondent | Greg Shipp BIO-MEDICAL RESEARCH, LTD. 14900 SWEITZER LN. SUITE 200 Laurel, MD 20707 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-16 |
| Decision Date | 1998-02-27 |
| Summary: | summary |