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 |