The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Medistim Xp, Type 281 And Meditens Xp, Type 458.
| Device ID | K082011 |
| 510k Number | K082011 |
| Device Name: | MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK WEST Galway, IE |
| Contact | Anne-marie Keenan |
| Correspondent | Anne-marie Keenan BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK WEST Galway, IE |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-15 |
| Decision Date | 2008-11-28 |
| Summary: | summary |