The following data is part of a premarket notification filed by Lunar Radiation Corp. with the FDA for Dpx Bone Densitometer.
Device ID | K873296 |
510k Number | K873296 |
Device Name: | DPX BONE DENSITOMETER |
Classification | Densitometer, Bone |
Applicant | LUNAR RADIATION CORP. 313 W. BELTLINE HIGHWAY Madison, WI 53713 |
Contact | Mazess, Phd |
Correspondent | Mazess, Phd LUNAR RADIATION CORP. 313 W. 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 | 1987-08-17 |
Decision Date | 1988-06-06 |