Device Classification Name |
instrument for auto reader & interpretation of overnight suscept. systems
|
510(k) Number |
K911400 |
Device Name |
WALKAWAY TM 40 |
Applicant |
BAXTER HEALTHCARE CORP. |
1584 ENTERPRISE BLVD. |
WEST SACRAMENTO,
CA
95691
|
|
Applicant Contact |
KARLA TOMFOHRDE |
Correspondent |
BAXTER HEALTHCARE CORP. |
1584 ENTERPRISE BLVD. |
WEST SACRAMENTO,
CA
95691
|
|
Correspondent Contact |
KARLA TOMFOHRDE |
Regulation Number | 866.1640
|
Classification Product Code |
|
Date Received | 03/29/1991 |
Decision Date | 11/19/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|