The following data is part of a premarket notification filed by Lunar Corp. with the FDA for Pixi Bone Densitometer.
Device ID | K970224 |
510k Number | K970224 |
Device Name: | PIXI 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 | 1997-01-21 |
Decision Date | 1997-04-16 |
Summary: | summary |