The following data is part of a premarket notification filed by Norland Corp. with the FDA for Norland Model Xr-26 X-ray Bone Densitometer.
| Device ID | K881865 |
| 510k Number | K881865 |
| Device Name: | NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER |
| Classification | Densitometer, Bone |
| Applicant | NORLAND CORP. W6340 HACKBARTH RD. Fort Atkinson, WI 53538 |
| Contact | W Schwalenberg |
| Correspondent | W 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 | 1988-05-04 |
| Decision Date | 1989-03-14 |