Device Classification Name |
Meter, Conductivity, Non-Remote
|
510(k) Number |
K920810 |
Device Name |
NEO-STAT 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 | 02/21/1992 |
Decision Date | 01/15/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|