The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for System-arms, Model 390,e60.
Device ID | K072553 |
510k Number | K072553 |
Device Name: | SYSTEM-ARMS, MODEL 390,E60 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-10 |
Decision Date | 2007-12-14 |
Summary: | summary |