The following data is part of a premarket notification filed by Schick Technologies, Inc. with the FDA for Accudexa Bone Densitometer.
| Device ID | K981124 |
| 510k Number | K981124 |
| Device Name: | ACCUDEXA BONE DENSITOMETER |
| Classification | Densitometer, Bone |
| Applicant | SCHICK TECHNOLOGIES, INC. 12300 TWINBROOK PARKWAY, SUITE 625 Rockville, MD 20852 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey SCHICK TECHNOLOGIES, INC. 12300 TWINBROOK PARKWAY, SUITE 625 Rockville, MD 20852 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-27 |
| Decision Date | 1998-06-04 |
| Summary: | summary |