Device Classification Name |
System, Gastrointestinal Motility (Electrical)
|
510(k) Number |
K980980 |
Device Name |
MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50 |
Applicant |
KONIGSBERG INSTRUMENTS, INC. |
2000 FOOTHILL BLVD. |
PASADENA,
CA
91107
|
|
Applicant Contact |
ARLIN HANSON |
Correspondent |
KONIGSBERG INSTRUMENTS, INC. |
2000 FOOTHILL BLVD. |
PASADENA,
CA
91107
|
|
Correspondent Contact |
ARLIN HANSON |
Regulation Number | 876.1725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/17/1998 |
Decision Date | 06/15/1998 |
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
|
|
|