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 K122927
Device Name OXICARE FINGERTIP PULSE OXIMETER
Applicant
Delbio Incorporated
3f & 6f, No 252 Shangying Rd.
Taoyuan County
Guishan Industrial Zone,  TW 33341
Applicant Contact NICKY PAN
Correspondent
Delbio Incorporated
3f & 6f, No 252 Shangying Rd.
Taoyuan County
Guishan Industrial Zone,  TW 33341
Correspondent Contact NICKY PAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/24/2012
Decision Date 12/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-