The following data is part of a premarket notification filed by Idt Technology Limited with the FDA for Oregon Scintific.
| Device ID | K131245 |
| 510k Number | K131245 |
| Device Name: | OREGON SCINTIFIC |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | IDT TECHNOLOGY LIMITED BLOCK 33, IDT TECHNOLOGY LIMITED, CHENTIAN INDUSTRIAL ESTATE, XIXIANG, BAOAN Shenzhen,, CN Ch |
| Contact | Lily Li |
| Correspondent | Lily Li IDT TECHNOLOGY LIMITED BLOCK 33, IDT TECHNOLOGY LIMITED, CHENTIAN INDUSTRIAL ESTATE, XIXIANG, BAOAN Shenzhen,, CN Ch |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-01 |
| Decision Date | 2014-01-17 |