The following data is part of a premarket notification filed by Suzhou Jj Meter Co., Ltd. with the FDA for Sphygmomanometer.
Device ID | K141392 |
510k Number | K141392 |
Device Name: | SPHYGMOMANOMETER |
Classification | Blood Pressure Cuff |
Applicant | SUZHOU JJ METER CO., LTD. R1508, EAST BLDG, YIHAI PLAZA CHUANGYE RD. NANSHAN DISTRICT Shenzhen, Guangdong, CN 518054 |
Contact | Long Yang |
Correspondent | Long Yang SUZHOU JJ METER CO., LTD. R1508, EAST BLDG, YIHAI PLAZA CHUANGYE RD. NANSHAN DISTRICT Shenzhen, Guangdong, CN 518054 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-27 |
Decision Date | 2014-07-02 |
Summary: | summary |