The following data is part of a premarket notification filed by Ge Medical Systems Lunar with the FDA for Ge Lunar Body Composition Software.
| Device ID | K071570 |
| 510k Number | K071570 |
| Device Name: | GE LUNAR BODY COMPOSITION SOFTWARE |
| Classification | Densitometer, Bone |
| Applicant | GE MEDICAL SYSTEMS LUNAR 726 HEARTLAND TRAIL Madison, WI 53717 |
| Contact | James P Raskob |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-06-08 |
| Decision Date | 2007-06-27 |
| Summary: | summary |