The following data is part of a premarket notification filed by Contec Medical System Co., Ltd. with the FDA for Contec Oxygen Concentrator.
| Device ID | K180837 |
| 510k Number | K180837 |
| Device Name: | CONTEC Oxygen Concentrator |
| Classification | Generator, Oxygen, Portable |
| Applicant | Contec Medical System Co., Ltd. No. 112 Qinhuang West Street, Economic & Technical Development Zone Qinhuangdao, CN 066004 |
| Contact | Xueyong Li |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FanShan District, Beijing, CN 102401 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-30 |
| Decision Date | 2019-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945040104650 | K180837 | 000 |
| 06945040105565 | K180837 | 000 |