NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR


Device Classification Name

oximeter, tissue saturation

510(k) Number K112826
Device Name NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR
Applicant
MOOR INSTRUMENTS LTD.
millwey
axminster, devon, 

GB

ex135hu

Applicant Contact xiabing huang huang
Correspondent
MOOR INSTRUMENTS LTD.
millwey
axminster, devon, 

GB

ex135hu

Correspodent Contact xiabing huang huang
Regulation Number 870.2700
Classification Product Code
MUD  
Date Received 09/28/2011
Decision Date 10/10/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No