• 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 K202173
Device Name Pulse Oximeter
Applicant
Shenzhen AOJ Medical Technology Co., Ltd.
601, 6th floor, B2 Building, An'le Industrial Park
#172 Hangcheng Avenue
Shenzhen,  CN 518126
Applicant Contact Wendy Lin
Correspondent
Shenzhen AOJ Medical Technology Co., Ltd.
601, 6th floor, B2 Building, An'le Industrial Park
#172 Hangcheng Avenue
Shenzhen,  CN 518126
Correspondent Contact Wendy Lin
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/03/2020
Decision Date 12/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-