The following data is part of a premarket notification filed by De Gotzen S.r.l. with the FDA for X-mind Unity.
| Device ID | K132378 |
| 510k Number | K132378 |
| Device Name: | X-MIND UNITY |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | DE GOTZEN S.R.L. VIA ROMA 45 Olgiate Olona, Varese, IT 21057 |
| Contact | Maurizio De Gotzen |
| Correspondent | Maurizio De Gotzen DE GOTZEN S.R.L. VIA ROMA 45 Olgiate Olona, Varese, IT 21057 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-31 |
| Decision Date | 2014-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D804W08001520 | K132378 | 000 |
| D804W08000060 | K132378 | 000 |
| D804W08000050 | K132378 | 000 |
| D804W08000040 | K132378 | 000 |
| D804W08000030 | K132378 | 000 |
| D804W08000020 | K132378 | 000 |
| D804W08000010 | K132378 | 000 |
| D804W08000000 | K132378 | 000 |
| D804W08000930 | K132378 | 000 |
| 03760262650661 | K132378 | 000 |
| 03760262650654 | K132378 | 000 |
| 03760262650647 | K132378 | 000 |
| 03760262650630 | K132378 | 000 |
| D804W08000070 | K132378 | 000 |
| D804W08000080 | K132378 | 000 |
| D804W08000090 | K132378 | 000 |
| D804W08001510 | K132378 | 000 |
| D804W08000910 | K132378 | 000 |
| D804W08000850 | K132378 | 000 |
| D804W08000230 | K132378 | 000 |
| D804W08000170 | K132378 | 000 |
| D804W08000160 | K132378 | 000 |
| D804W08000150 | K132378 | 000 |
| D804W08000140 | K132378 | 000 |
| D804W08000130 | K132378 | 000 |
| D804W08000120 | K132378 | 000 |
| D804W08000110 | K132378 | 000 |
| D804W08000100 | K132378 | 000 |
| D804W08000830 | K132378 | 000 |