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 K201468
Device Name Pulse Oximeter
Applicant
Shenzhen Creative Industry Co., Ltd.
Floor 5, BLD 9 Baiwangxin High-Tech Industrial Park
Songbai Road, Xili Street
Shenzhen,  CN 518110
Applicant Contact Jia Wang
Correspondent
International Regulatory Consultants (IRC)
2950 E Lindrick Drive
Chandler,  AZ  85249
Correspondent Contact Charles Mack
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/02/2020
Decision Date 01/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-