The following data is part of a premarket notification filed by Hunan Accurate Bio-medical Technology Co., Ltd. with the FDA for Pulse Oximeter.
| Device ID | K171241 |
| 510k Number | K171241 |
| Device Name: | Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Hunan Accurate Bio-Medical Technology Co., Ltd. M8-613, No.8, Lutian Road, Changsha National Hi-Tech Industrial Development Changsha, CN 410208 |
| Contact | Zhou Le |
| Correspondent | Zhou Le Hunan Accurate Bio-Medical Technology Co., Ltd. M8-613, No.8, Lutian Road, Changsha National Hi-Tech Industrial Development Changsha, CN 410208 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-27 |
| Decision Date | 2018-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06927394533331 | K171241 | 000 |
| 00817643023071 | K171241 | 000 |