• 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 K172792
Device Name Handheld Pulse Oximeter, Model SP-20
Shenzhen Creative Industry Co., Ltd.
2/F, Block 3, Nanyou Tian'an Industry Town
Shenzhen,  CN 518054
Applicant Contact Jia Wang
2091 Oak Drive
Lake Havasu City,  AZ  86406
Correspondent Contact Charlie Mack
Regulation Number870.2700
Classification Product Code
Subsequent Product Code
Date Received09/15/2017
Decision Date 11/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No