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 K131818
Device Name VITAL SIGNS MONITOR
Applicant
Edan Instruments, Inc.
Equipments Park, Nanhai Rd.
1019 # Shekou Nanshan
Shenzhen, Guangdong,  CN 518067
Applicant Contact QUEENA CHEN
Correspondent
Edan Instruments, Inc.
Equipments Park, Nanhai Rd.
1019 # Shekou Nanshan
Shenzhen, Guangdong,  CN 518067
Correspondent Contact QUEENA CHEN
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Codes
DXN   FLL  
Date Received06/20/2013
Decision Date 08/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-