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 K241351
Device Name Blood Pressure Monitor (TMB-2092-G)
Applicant
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, # 105, Dongli Rd.,
Torch Development District
Zhongshan,  CN 528437
Applicant Contact Fan Jerry
Correspondent
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, # 105, Dongli Rd.,
Torch Development District
Zhongshan,  CN 528437
Correspondent Contact Fan Jerry
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/13/2024
Decision Date 08/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-