The following data is part of a premarket notification filed by Lunar Radiation Corp. with the FDA for Bone Mineral Analyzer Controller.
Device ID | K810159 |
510k Number | K810159 |
Device Name: | BONE MINERAL ANALYZER CONTROLLER |
Classification | Densitometer, Bone |
Applicant | LUNAR RADIATION CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KGI |
CFR Regulation Number | 892.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-21 |
Decision Date | 1981-02-12 |