The following data is part of a premarket notification filed by Orantech Inc. with the FDA for Disposable Spo2 Sensors, Reusable Spo2 Sensors.
| Device ID | K181270 |
| 510k Number | K181270 |
| Device Name: | Disposable SpO2 Sensors, Reusable SpO2 Sensors |
| Classification | Oximeter |
| Applicant | Orantech Inc. Zone#A, 4F, 1st Bld, 7th Industrial Zone, Yulv Community, GongMing Shenzhen, CN 518132 |
| Contact | Yunxi Xiong |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-14 |
| Decision Date | 2018-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B817102081 | K181270 | 000 |
| 06941691973775 | K181270 | 000 |
| 06941691973805 | K181270 | 000 |
| 06941691973812 | K181270 | 000 |
| 06941691973829 | K181270 | 000 |
| 06941691973836 | K181270 | 000 |
| 06941691973881 | K181270 | 000 |
| 06941691967019 | K181270 | 000 |
| 06941691967026 | K181270 | 000 |
| 06941691968054 | K181270 | 000 |
| 06941691968078 | K181270 | 000 |
| 06941691968085 | K181270 | 000 |
| 06941691968313 | K181270 | 000 |
| 06941691970149 | K181270 | 000 |
| 06941691970248 | K181270 | 000 |
| 06941691907329 | K181270 | 000 |
| 06941691907442 | K181270 | 000 |
| 06941691927785 | K181270 | 000 |
| 06941691973553 | K181270 | 000 |