MIROXI


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

Correspodent Contact simon fowler
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 04/11/2008
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