Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K241613
Device Name Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)
Applicant
Shenzhen Hbcare Technology Co.,Ltd
A208, Block A And B, #1 Chuangjin, District 28,
Dalang Community, Xin'An St., Baoan
Shenzhen,  CN 516000
Applicant Contact XuYu Lee
Correspondent
Shenzhen Hbcare Technology Co.,Ltd
A208, Block A And B, #1 Chuangjin, District 28,
Dalang Community, Xin'An St., Baoan
Shenzhen,  CN 516000
Correspondent Contact XuYu Lee
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/05/2024
Decision Date 10/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-