The following data is part of a premarket notification filed by Edlen Imaging Llc with the FDA for Edlen Imaging - Gemini Dusb.
| Device ID | K103290 |
| 510k Number | K103290 |
| Device Name: | EDLEN IMAGING - GEMINI DUSB |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | EDLEN IMAGING LLC 3707 N 7TH STREET SUITE 125 Phoenix, AZ 85014 |
| Contact | Felix Hovsepian |
| Correspondent | Felix Hovsepian EDLEN IMAGING LLC 3707 N 7TH STREET SUITE 125 Phoenix, AZ 85014 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-08 |
| Decision Date | 2011-09-19 |
| Summary: | summary |