MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR


Device Classification Name

thermometer, electronic, clinical

510(k) Number K110956
Device Name MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR
Applicant
MEDIVANCE, INC.
321 south taylor ave, ste 200
louisville, 
CO 
80027

Applicant Contact lynne aronson
Correspondent
MEDIVANCE, INC.
321 south taylor ave, ste 200
louisville, 
CO 
80027

Correspodent Contact lynne aronson
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 04/05/2011
Decision Date 07/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No