The following data is part of a premarket notification filed by Shotwell & Carr, Inc. with the FDA for Dtx-200 Bone Densitometer.
| Device ID | K961011 |
| 510k Number | K961011 |
| Device Name: | DTX-200 BONE DENSITOMETER |
| Classification | Densitometer, Bone |
| Applicant | SHOTWELL & CARR, INC. 3003 LBJ FREEWAY, SUITE 100 Dallas, TX 75234 -7755 |
| Contact | Bert Hudson |
| Correspondent | Bert Hudson SHOTWELL & CARR, INC. 3003 LBJ FREEWAY, SUITE 100 Dallas, TX 75234 -7755 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-13 |
| Decision Date | 1996-07-05 |
| Summary: | summary |