The following data is part of a premarket notification filed by Norland Corp. with the FDA for Fracture Risk Assessment For The Norland Sxa 3000 Bone Densitometer.
| Device ID | K980289 |
| 510k Number | K980289 |
| Device Name: | FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER |
| Classification | Densitometer, Bone |
| Applicant | NORLAND CORP. WEST 6340 HACKBARTH RD. Fort Atkinson, WI 53538 -8999 |
| Contact | Terry Schwalenberg |
| Correspondent | Terry Schwalenberg NORLAND CORP. WEST 6340 HACKBARTH RD. Fort Atkinson, WI 53538 -8999 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-26 |
| Decision Date | 1998-06-12 |
| Summary: | summary |