Device Classification Name |
Monitor, Esophageal Motility, Anorectal Motility, And Tube
|
510(k) Number |
K964804 |
Device Name |
FLEXILOG LS |
Applicant |
OAKFIELD INSTRUMENTS, LTD. |
OAKFIELD INDUSTRIAL ESTATE |
STANTON HARCOURT RD, EYNSHAM |
OXON OX8 1JA ENGLAND,
GB
|
|
Applicant Contact |
JOHN GIDDINGS |
Correspondent |
OAKFIELD INSTRUMENTS, LTD. |
OAKFIELD INDUSTRIAL ESTATE |
STANTON HARCOURT RD, EYNSHAM |
OXON OX8 1JA ENGLAND,
GB
|
|
Correspondent Contact |
JOHN GIDDINGS |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 11/29/1996 |
Decision Date | 08/06/1997 |
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
|
|
|