The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Bmr Face.
| Device ID | K103031 |
| 510k Number | K103031 |
| Device Name: | BMR FACE |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | BIO-MEDICAL RESEARCH, LTD. BMR HOUSE PARKMORE BUSINESS PARK, WEST Galway, IE Ei |
| Contact | Anne-marie Keenan |
| Correspondent | Anne-marie Keenan BIO-MEDICAL RESEARCH, LTD. BMR HOUSE PARKMORE BUSINESS PARK, WEST Galway, IE Ei |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-12 |
| Decision Date | 2011-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05099058724025 | K103031 | 000 |