Device Classification Name |
Tube, Feeding
|
510(k) Number |
K120815 |
Device Name |
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE |
Applicant |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1099
|
|
Applicant Contact |
PETER SCHIPELLITI |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1099
|
|
Correspondent Contact |
PETER SCHIPELLITI |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 03/19/2012 |
Decision Date | 03/06/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|