Device Classification Name |
electrocardiograph, ambulatory, with analysis algorithm
|
510(k) Number |
K992706 |
Device Name |
GALIX GBI -3S-LP |
Applicant |
GALIX BIOMEDICAL INSTRUMENTATION, INC. |
2555 COLLINS AVE., C-5 |
MIAMI BEACH,
FL
33140
|
|
Applicant Contact |
JORDAN GAVRIELIDES |
Correspondent |
GALIX BIOMEDICAL INSTRUMENTATION, INC. |
2555 COLLINS AVE., C-5 |
MIAMI BEACH,
FL
33140
|
|
Correspondent Contact |
JORDAN GAVRIELIDES |
Regulation Number | 870.2800
|
Classification Product Code |
|
Date Received | 08/12/1999 |
Decision Date | 03/15/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|