The following data is part of a premarket notification filed by Shenyang Canta Medical Tech Co., Ltd. with the FDA for Hg Oxygen Concentrator, Models Hg5-w & Hg5-wn.
| Device ID | K081508 |
| 510k Number | K081508 |
| Device Name: | HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN |
| Classification | Generator, Oxygen, Portable |
| Applicant | SHENYANG CANTA MEDICAL TECH CO., LTD. SUITE 8D, NO. 19, LANE 999 ZHONGSHAN NO.2 ROAD (S) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHENYANG CANTA MEDICAL TECH CO., LTD. SUITE 8D, NO. 19, LANE 999 ZHONGSHAN NO.2 ROAD (S) Shanghai, CN 200030 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-29 |
| Decision Date | 2008-08-27 |
| Summary: | summary |