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 transducer, blood-pressure, extravascular
510(k) Number K152472
Device Name Disposable Pressure Transducer
Applicant
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
305#TANGGONG ROAD, PAOJIANG INDUSTRIAL ZONE
SHAOXING,  CN 312071
Applicant Contact Junbin Hu
Correspondent
MEDWHEAT (SHANGHAI) MEDICAL TECHNOLOGY CO.,LTD..
YANGPU DISTRIST LIAOYUAN EAST ROAD SHUANGYANG
FIRST SUITE NO.33 ROOM 303
SHANGHAI,  CN 200093
Correspondent Contact Jonathan Hu
Regulation Number870.2850
Classification Product Code
DRS  
Date Received08/31/2015
Decision Date 10/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-