The following data is part of a premarket notification filed by Qingdao Kingon Medical Science And Technology Co., Ltd. with the FDA for Portable Oxygen Concentrator, Model: P2-e6.
| Device ID | K210371 |
| 510k Number | K210371 |
| Device Name: | Portable Oxygen Concentrator, Model: P2-E6 |
| Classification | Generator, Oxygen, Portable |
| Applicant | Qingdao Kingon Medical Science And Technology Co., Ltd. Room 301-302, No.15 HanchengRoad Qingdao Free Trade Zone, CN 266555 |
| Contact | Zhang Benrong |
| Correspondent | You Yijie Qimmiq Medical Consulting Service Co., Ltd RM.1711, Building K, NO.101 Science Ave International Creative Valley Guangzhou, CN 510663 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-08 |
| Decision Date | 2022-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971882890093 | K210371 | 000 |
| 06971882890161 | K210371 | 000 |