Device Classification Name |
System, Gastrointestinal Motility (Electrical)
|
510(k) Number |
K082056 |
Device Name |
ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 |
Applicant |
LIFE-TECH, INC. |
4235 GREENBRIAR DR. |
STAFFORD,
TX
77477 -3995
|
|
Applicant Contact |
JEFF KASOFF |
Correspondent |
LIFE-TECH, INC. |
4235 GREENBRIAR DR. |
STAFFORD,
TX
77477 -3995
|
|
Correspondent Contact |
JEFF KASOFF |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 07/21/2008 |
Decision Date | 11/07/2008 |
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
|
|
|