Device Classification Name |
Recorder, Magnetic Tape, Medical
|
510(k) Number |
K971670 |
Device Name |
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER |
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 | 05/06/1997 |
Decision Date | 01/29/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|