The following data is part of a premarket notification filed by Lunar Corp. with the FDA for Lunar Expert.
| Device ID | K945526 |
| 510k Number | K945526 |
| Device Name: | LUNAR EXPERT |
| Classification | Densitometer, Bone |
| Applicant | LUNAR CORP. 313 WEST BELTLINE HIGHWAY Madison, WI 53713 |
| Contact | Richard B Mazess |
| Correspondent | Richard B Mazess 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 | 1994-11-10 |
| Decision Date | 1995-04-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LUNAR EXPERT 74619747 1938837 Dead/Cancelled |
Lunar Corporation 1995-01-10 |