The following data is part of a premarket notification filed by Ge Lunar Corp. with the FDA for Dpx Series Bravo Duo Bone Densitometer.
Device ID | K030962 |
510k Number | K030962 |
Device Name: | DPX SERIES BRAVO DUO BONE DENSITOMETER |
Classification | Densitometer, Bone |
Applicant | GE LUNAR CORP. 726 HEARTLAND TRAIL Madison, WI 53717 |
Contact | James P Raskob |
Correspondent | James P Raskob GE LUNAR CORP. 726 HEARTLAND TRAIL Madison, WI 53717 |
Product Code | KGI |
CFR Regulation Number | 892.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-27 |
Decision Date | 2003-07-25 |
Summary: | summary |