The following data is part of a premarket notification filed by Norland Corp. with the FDA for Forarm Opt/norland Xr Series X-ray Bone Densitomet.
| Device ID | K926019 |
| 510k Number | K926019 |
| Device Name: | FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET |
| Classification | Densitometer, Bone |
| Applicant | NORLAND CORP. W6340 HACKBARTH RD. Fort Atkinson, WI 53538 |
| Contact | Terry Schwalenberg |
| Correspondent | Terry Schwalenberg NORLAND CORP. W6340 HACKBARTH RD. Fort Atkinson, WI 53538 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-30 |
| Decision Date | 1994-09-23 |