The following data is part of a premarket notification filed by Medical And Scientific Enterprises, Inc. with the FDA for Dual Photon Bone Densitometer.
| Device ID | K861233 |
| 510k Number | K861233 |
| Device Name: | DUAL PHOTON BONE DENSITOMETER |
| Classification | Densitometer, Bone |
| Applicant | MEDICAL AND SCIENTIFIC ENTERPRISES, INC. P.O. BOX 661 Concord, MA 01742 |
| Contact | Eduard J Botz |
| Correspondent | Eduard J Botz MEDICAL AND SCIENTIFIC ENTERPRISES, INC. P.O. BOX 661 Concord, MA 01742 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-01 |
| Decision Date | 1987-03-03 |