The following data is part of a premarket notification filed by Cuattro, Llc with the FDA for Cuattro Unomd.
| Device ID | K093480 |
| 510k Number | K093480 |
| Device Name: | CUATTRO UNOMD |
| Classification | System, Image Processing, Radiological |
| Applicant | CUATTRO, LLC 40 BRAM BAY ROAD Hoptacong, NJ 07843 |
| Contact | Mark Skeels |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-11-09 |
| Decision Date | 2010-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B269SWR00021MD0 | K093480 | 000 |