The following data is part of a premarket notification filed by Shenzhen Vistar Medical Supplies Co., Ltd. with the FDA for Reusable Blood Pressure Cuff.
Device ID | K152468 |
510k Number | K152468 |
Device Name: | Reusable Blood Pressure Cuff |
Classification | Blood Pressure Cuff |
Applicant | Shenzhen Vistar Medical Supplies Co., Ltd. 808, Hanhaida Bldg., No. 7 Songgang Blvd. Songgang Town Shenzhen, CN 518105 |
Contact | Zhenxun Chen |
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 | 2015-08-31 |
Decision Date | 2015-10-29 |
Summary: | summary |