The following data is part of a premarket notification filed by Densitas, Inc. with the FDA for Dm-density.
| Device ID | K170540 |
| 510k Number | K170540 |
| Device Name: | DM-Density |
| Classification | System, Image Processing, Radiological |
| Applicant | Densitas, Inc. 1344 Summer Street, Suite 311.2 Halifax, CA B3h 0a8 |
| Contact | Mo Abdolell |
| Correspondent | Ken Pilgrim Emergo Group, Inc. 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-23 |
| Decision Date | 2018-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10627843712760 | K170540 | 000 |
| 10627843712753 | K170540 | 000 |