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 Dpx & Prodigy Series Dexa Bone Densitometers With Mobile Kit.
| Device ID | K072439 |
| 510k Number | K072439 |
| Device Name: | GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT |
| Classification | Densitometer, Bone |
| Applicant | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA 726 HEARTLAND TRAIL Madison, WI 53717 |
| Contact | James P Raskob |
| Correspondent | James P 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-30 |
| Decision Date | 2007-09-14 |
| Summary: | summary |