The following data is part of a premarket notification filed by Guangzhou Life Light Electronic Technology Co., Ltd. with the FDA for Owgels Oxygen Concentrator.
| Device ID | K191875 |
| 510k Number | K191875 |
| Device Name: | Owgels Oxygen Concentrator |
| Classification | Generator, Oxygen, Portable |
| Applicant | Guangzhou Life Light Electronic Technology Co., Ltd. No. A102, No. 1 Kesheng Road, Baiyun District GUangzhou, CN 510540 |
| Contact | Erika Meng |
| Correspondent | Iris Fung SGS-CSTC Standards Technical Services Co., Ltd. 108 Kezhu Road Scientech Park Guangzhou Economic & Technology Guangzhou, CN 510060 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-12 |
| Decision Date | 2020-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815027012512 | K191875 | 000 |
| 00860009971103 | K191875 | 000 |