The following data is part of a premarket notification filed by Cuattro, Llc with the FDA for Cuattrodr.
| Device ID | K161937 |
| 510k Number | K161937 |
| Device Name: | CuattroDR |
| Classification | System, X-ray, Stationary |
| Applicant | Cuattro, LLC 3760 Rocky Mountain Avenue Loveland, CO 80538 |
| Contact | Matthew Taylor |
| Correspondent | Matthew Taylor Cuattro, LLC 3760 Rocky Mountain Avenue Loveland, CO 80538 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-14 |
| Decision Date | 2016-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B269SWR00069MD0 | K161937 | 000 |