The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Dia with the FDA for Ge Lunar Visceral Fat Software.
| Device ID | K103730 |
| 510k Number | K103730 |
| Device Name: | GE LUNAR VISCERAL FAT SOFTWARE |
| Classification | Densitometer, Bone |
| Applicant | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA 3030 OHMEDA DRIVE Madison, WI 53718 |
| Contact | Chris Paulik |
| Correspondent | Chris Paulik GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA 3030 OHMEDA DRIVE Madison, WI 53718 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-21 |
| Decision Date | 2011-05-06 |
| Summary: | summary |