ESSENTIAL MRI PATIENT MONITOR


Device Classification Name

oximeter

510(k) Number K103700
Device Name ESSENTIAL MRI PATIENT MONITOR
Applicant
INVIVO CORPORATION
12151 research pkwy
orlando, 
FL 
32826

Applicant Contact rusty kelly
Correspondent
INVIVO CORPORATION
12151 research pkwy
orlando, 
FL 
32826

Correspodent Contact rusty kelly
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 12/20/2010
Decision Date 03/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No