The following data is part of a premarket notification filed by Norland Medical Systems, Inc. with the FDA for Xr 46 Dxa (central) Bone Densitometer, Model Xr 46.
| Device ID | K992125 |
| 510k Number | K992125 |
| Device Name: | XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 |
| Classification | Densitometer, Bone |
| Applicant | NORLAND MEDICAL SYSTEMS, INC. W-6340 HACKBARTH RD. Fort Atkinson, WI 53538 -8999 |
| Contact | Terry Schwalenberg |
| Correspondent | John Monahan NORLAND MEDICAL SYSTEMS, INC. 31 Gordan Road Piscataway, NJ 08854 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-23 |
| Decision Date | 1999-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866955000461 | K992125 | 000 |
| 00866955000454 | K992125 | 000 |
| 00866955000447 | K992125 | 000 |
| 00866955000430 | K992125 | 000 |
| 00866955000423 | K992125 | 000 |
| 00866955000416 | K992125 | 000 |
| 00866955000409 | K992125 | 000 |