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 Oximeter
510(k) Number K232989
Device Name Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)
Applicant
Shenzhen AOJ Medical Technology Co., Ltd.
Rm.301&4f, Block A, Bldg. A,Ingfa Intelligent Manufacturing
Park,Xiaweiyuan,Gushu Community,Xixiang St., Bao'An District
Shenzhen,  CN 518126
Applicant Contact Jack Wang
Correspondent
Shenzhen AOJ Medical Technology Co., Ltd.
Rm.301&4f, Block A, Bldg. A,Ingfa Intelligent Manufacturing
Park,Xiaweiyuan,Gushu Community,Xixiang St., Bao'An District
Shenzhen,  CN 518126
Correspondent Contact Jack Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/22/2023
Decision Date 07/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-