The following data is part of a premarket notification filed by Gentec (shanghai) Corporation with the FDA for Gmx Series Medical Air/oxygen Blender.
| Device ID | K142291 |
| 510k Number | K142291 |
| Device Name: | GMX Series Medical Air/Oxygen Blender |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | GENTEC (SHANGHAI) CORPORATION NO.1988 Yushu Road Songjiang District, CN 201699 |
| Contact | Dongjian Lin |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Consulting Co., Ltd 7th Floor, 982 Congyun Road Baiyun District, CN 510420 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-18 |
| Decision Date | 2015-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970966662601 | K142291 | 000 |
| 06970966662595 | K142291 | 000 |
| 06970966662526 | K142291 | 000 |
| 06970966662502 | K142291 | 000 |
| 06970966662496 | K142291 | 000 |
| 06970966660027 | K142291 | 000 |
| 06970966666371 | K142291 | 000 |