The following data is part of a premarket notification filed by Minxray, Inc. with the FDA for Minxray, Model: Bpd60.
| Device ID | K091255 |
| 510k Number | K091255 |
| Device Name: | MINXRAY, MODEL: BPD60 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | MINXRAY, INC. 333 MILFORD RD. Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm MINXRAY, INC. 333 MILFORD RD. Deerfield, IL 60015 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-29 |
| Decision Date | 2010-05-12 |