The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for System-mini, Models: 390, E30.
| Device ID | K072294 |
| 510k Number | K072294 |
| Device Name: | SYSTEM-MINI, MODELS: 390, E30 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| 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 | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-16 |
| Decision Date | 2007-10-25 |
| Summary: | summary |