The following data is part of a premarket notification filed by Norland Corp. with the FDA for Model Pdexa Bone Densitometer.
| Device ID | K931996 |
| 510k Number | K931996 |
| Device Name: | MODEL PDEXA BONE DENSITOMETER |
| Classification | Densitometer, Bone |
| Applicant | NORLAND CORP. W6340 HACKBARTH RD. Fort Atkinson, WI 53538 |
| Contact | Terry Schwalenberg |
| Correspondent | John Monahan NORLAND CORP. 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 | 1993-04-23 |
| Decision Date | 1995-02-01 |