Device Classification Name |
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
|
510(k) Number |
K974775 |
Device Name |
SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE |
Applicant |
AIRTRONIC SERVICES, INC. |
116 NORTH LIVELY BLVD. |
ELK GROVE VILLAGE,
IL
60007
|
|
Applicant Contact |
ROBERT E WALTER |
Correspondent |
AIRTRONIC SERVICES, INC. |
116 NORTH LIVELY BLVD. |
ELK GROVE VILLAGE,
IL
60007
|
|
Correspondent Contact |
ROBERT E WALTER |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 12/22/1997 |
Decision Date | 02/19/1998 |
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
|
|
|