Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K992181 |
Device Name |
TRIP TONOMETRY CATHETER, 8F |
Applicant |
DATEX-OHMEDA, INC. |
3 HIGHWOOD DR. |
TEWKSBURY,
MA
01876
|
|
Applicant Contact |
JOEL KENT |
Correspondent |
DATEX-OHMEDA, INC. |
3 HIGHWOOD DR. |
TEWKSBURY,
MA
01876
|
|
Correspondent Contact |
JOEL KENT |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 06/28/1999 |
Decision Date | 08/24/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|