The following data is part of a premarket notification filed by Wenzhou Bokang Instruments Co., Ltd with the FDA for Aneroid Sphygmomanometer.
Device ID | K173246 |
510k Number | K173246 |
Device Name: | ANEROID SPHYGMOMANOMETER |
Classification | Blood Pressure Cuff |
Applicant | Wenzhou Bokang Instruments Co., Ltd No. 1500 Haining Road, Haibin Longwan Wenzhou, CN 325024 |
Contact | Youhua Xiang |
Correspondent | Youhua Xiang Wenzhou Bokang Instruments Co., Ltd No. 1500 Haining Road, Haibin Longwan Wenzhou, CN 325024 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-06 |
Decision Date | 2018-05-30 |
Summary: | summary |