Device Classification Name |
Meter, Conductivity, Non-Remote
|
510(k) Number |
K955298 |
Device Name |
PHOENIX DIALYSATE METER |
Applicant |
AUTOMATA MEDICAL INSTRUMENTATION, INC. |
7830 EAST REDFIELD RD., |
SUITE 12 |
SCOTTSDALE,
AZ
85260
|
|
Applicant Contact |
LINDA V MASANO |
Correspondent |
AUTOMATA MEDICAL INSTRUMENTATION, INC. |
7830 EAST REDFIELD RD., |
SUITE 12 |
SCOTTSDALE,
AZ
85260
|
|
Correspondent Contact |
LINDA V MASANO |
Regulation Number | 876.5820 |
Classification Product Code |
|
Date Received | 11/20/1995 |
Decision Date | 02/29/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|