The following data is part of a premarket notification filed by Humanray Co,ltd with the FDA for Ezsensor P Digital Intraoral Sensor.
| Device ID | K121132 |
| 510k Number | K121132 |
| Device Name: | EZSENSOR P DIGITAL INTRAORAL SENSOR |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | HUMANRAY CO,LTD 12946 KIMBERLEY LN Houston, TX 77079 |
| Contact | Dave Kim |
| Correspondent | Dave Kim HUMANRAY CO,LTD 12946 KIMBERLEY LN Houston, TX 77079 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-13 |
| Decision Date | 2012-05-10 |
| Summary: | summary |