The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Osteopak Bmd (bone Mineral Densitometer).
| Device ID | K861515 |
| 510k Number | K861515 |
| Device Name: | OSTEOPAK BMD (BONE MINERAL DENSITOMETER) |
| Classification | Densitometer, Bone |
| Applicant | SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018 |
| Contact | Joseph P Stowell |
| Correspondent | Joseph P Stowell SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-23 |
| Decision Date | 1987-02-02 |