The following data is part of a premarket notification filed by Lunar Corp. with the FDA for Fracture Risk Assessment Option For Expert-xl Bone Densitometer.
| Device ID | K983269 |
| 510k Number | K983269 |
| Device Name: | FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER |
| Classification | Densitometer, Bone |
| Applicant | LUNAR CORP. 313 WEST BELTLINE HIGHWAY Madison, WI 53713 |
| Contact | Kenneth D Buroker |
| Correspondent | Kenneth D Buroker LUNAR CORP. 313 WEST BELTLINE HIGHWAY Madison, WI 53713 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-17 |
| Decision Date | 1998-11-18 |
| Summary: | summary |