The following data is part of a premarket notification filed by Sysmed (china) Co., Ltd with the FDA for Oxygen Concentrator.
| Device ID | K172234 |
| 510k Number | K172234 |
| Device Name: | Oxygen Concentrator |
| Classification | Generator, Oxygen, Portable |
| Applicant | SysMed (China) Co., Ltd 11-2-3 No. 17 Wensu Str., Hunnan New Dis. Shenyang, CN 110171 |
| Contact | Jian Yue |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-25 |
| Decision Date | 2018-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06955623000019 | K172234 | 000 |
| 06955623000033 | K172234 | 000 |