Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K993296 |
Device Name |
TRIP TONOMETRY CATHETER, 14F |
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 |
|
Subsequent Product Codes |
|
Date Received | 10/01/1999 |
Decision Date | 12/15/1999 |
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
|
|
|