The following data is part of a premarket notification filed by Danyang Jumao Healthcare Equipment Co.,ltd. with the FDA for Jumao Oxygen Concentrator, Model Jm-07000hi, Jm-07000i, Jm-07000.
| Device ID | K090007 |
| 510k Number | K090007 |
| Device Name: | JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000 |
| Classification | Generator, Oxygen, Portable |
| Applicant | DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. NO.89 SHUANGFENG ROAD, JIEPAI TOWN Danyang City,jiangsu Province, CN 212300 |
| Contact | Qing Wang |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-01-02 |
| Decision Date | 2009-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972855530022 | K090007 | 000 |
| 05060488571671 | K090007 | 000 |
| 00815027012376 | K090007 | 000 |
| 00092237623152 | K090007 | 000 |
| 06972855530282 | K090007 | 000 |
| 00369771003161 | K090007 | 000 |