The following data is part of a premarket notification filed by Norland Corp. with the FDA for Bone Densitometer.
| Device ID | K841463 |
| 510k Number | K841463 |
| Device Name: | BONE DENSITOMETER |
| Classification | Densitometer, Bone |
| Applicant | NORLAND 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 | 1984-04-09 |
| Decision Date | 1984-07-17 |