The following data is part of a premarket notification filed by Jazz Imaging Llc Dba Jazz Imaging with the FDA for Jazz Solo Sensor.
| Device ID | K213637 |
| 510k Number | K213637 |
| Device Name: | JAZZ Solo Sensor |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Jazz Imaging LLC Dba JAZZ Imaging San Jose, CA 95131 |
| Contact | Todd C Miller |
| Correspondent | Ed Johansen W. Edward Johansen 1239 Stanford Street, #205 Santa Monica, CA 90404 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-18 |
| Decision Date | 2021-12-10 |