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 K100815
Device Name OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316
Applicant
OXYPULSE
ONE MACDONAL CENTER
1 N. MACDONALD SUITE #8
MESA,  AZ  85201
Applicant Contact JAMES A DUNNING
Correspondent
OXYPULSE
ONE MACDONAL CENTER
1 N. MACDONALD SUITE #8
MESA,  AZ  85201
Correspondent Contact JAMES A DUNNING
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/23/2010
Decision Date 06/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-