The following data is part of a premarket notification filed by Shenzhen Aoj Medical Technology Co., Ltd. with the FDA for Pulse Oximeter.
| Device ID | K202173 |
| 510k Number | K202173 |
| Device Name: | Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Shenzhen AOJ Medical Technology Co., Ltd. 601, 6th Floor, B2 Building, An'le Industrial Park #172 Hangcheng Avenue Shenzhen, CN 518126 |
| Contact | Wendy Lin |
| Correspondent | Wendy Lin Shenzhen AOJ Medical Technology Co., Ltd. 601, 6th Floor, B2 Building, An'le Industrial Park #172 Hangcheng Avenue Shenzhen, CN 518126 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-03 |
| Decision Date | 2020-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972040110473 | K202173 | 000 |
| 06972040110466 | K202173 | 000 |
| 06972040110459 | K202173 | 000 |
| 06972040110442 | K202173 | 000 |
| 06972040110435 | K202173 | 000 |
| 06972040111067 | K202173 | 000 |
| 06972040112569 | K202173 | 000 |
| 06972040112552 | K202173 | 000 |