The following data is part of a premarket notification filed by Alara, Inc. with the FDA for Metriscan Bone Density System.
| Device ID | K000162 |
| 510k Number | K000162 |
| Device Name: | METRISCAN BONE DENSITY SYSTEM |
| Classification | Densitometer, Bone |
| Applicant | ALARA, INC. 2545 BARRINGTON CT. Hayward, CA 94545 -1134 |
| Contact | Diane M King |
| Correspondent | Diane M King ALARA, INC. 2545 BARRINGTON CT. Hayward, CA 94545 -1134 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-19 |
| Decision Date | 2000-05-12 |