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 Femur Strength Software.
| Device ID | K072664 |
| 510k Number | K072664 |
| Device Name: | GE LUNAR FEMUR STRENGTH SOFTWARE |
| Classification | Densitometer, Bone |
| Applicant | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA 726 HEARTLAND TRAIL Madison, WI 53717 |
| Contact | James Raskob |
| Correspondent | James Raskob GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA 726 HEARTLAND TRAIL Madison, WI 53717 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-20 |
| Decision Date | 2008-11-21 |
| Summary: | summary |