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 K081033
Device Name MIROXI
Applicant
MIR MEDICAL INTL. RESEARCH SRL
VIA DEL MAGGIOLINO 125
ROMA,  IT 00155
Applicant Contact SIMON FOWLER
Correspondent
MIR MEDICAL INTL. RESEARCH SRL
VIA DEL MAGGIOLINO 125
ROMA,  IT 00155
Correspondent Contact SIMON FOWLER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/11/2008
Decision Date 01/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-