The following data is part of a premarket notification filed by Jiaxing Zhongfa Medical Products Co., Ltd. with the FDA for Aneroid Sphygmomanometer.
Device ID | K151246 |
510k Number | K151246 |
Device Name: | Aneroid Sphygmomanometer |
Classification | Blood Pressure Cuff |
Applicant | Jiaxing Zhongfa Medical Products Co., Ltd. No.38 Building 1, Zhong Fa Group ZhuangShi Village, FengQiao Town, Nanhu Dst Jiaxing, CN 314008 |
Contact | Mao Xiaohua |
Correspondent | Ray Wang Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Chaoyang District Beijing, CN 100024 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-11 |
Decision Date | 2015-06-30 |
Summary: | summary |