The following data is part of a premarket notification filed by Dongguan Mars Medical Products Co., Ltd with the FDA for Aneroid Type Blood Pressure Kit.
| Device ID | K191209 |
| 510k Number | K191209 |
| Device Name: | Aneroid Type Blood Pressure Kit |
| Classification | Blood Pressure Cuff |
| Applicant | Dongguan Mars Medical Products Co., Ltd 381, Manfeng West Road, Manfeng Group Dani Village, Shatian Town, Dongguan Cit, CN 523993 |
| Contact | Lily Liao |
| Correspondent | Jinghua Zhou Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, CN 511660 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-06 |
| Decision Date | 2019-06-18 |