The following data is part of a premarket notification filed by Qingdao Kingon Medical Science And Technology Co. with the FDA for Kingon P2 Oxygen Concentrator.
| Device ID | K190304 |
| 510k Number | K190304 |
| Device Name: | Kingon P2 Oxygen Concentrator |
| Classification | Generator, Oxygen, Portable |
| Applicant | Qingdao Kingon Medical Science And Technology Co. 24th East Building, No. 252 Yanhe Road, Tianhe Industrial Park, Huangdao Qingdao, CN |
| Contact | Roman Huang |
| Correspondent | Roman Huang Elliot Medical Solutions Parkland Drive Cleveland Heights, OH 44106 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-12 |
| Decision Date | 2020-02-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971882890017 | K190304 | 000 |
| 06971882890178 | K190304 | 000 |