Device Classification Name |
Electrode, Electrocardiograph
|
510(k) Number |
K002230 |
Device Name |
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 |
Applicant |
CAMBRIDGE HEART, INC. |
20310 SW 48TH ST. |
FT. LAUDERDALE,
FL
33332
|
|
Applicant Contact |
JOHN GREENBAUM |
Correspondent |
CAMBRIDGE HEART, INC. |
20310 SW 48TH ST. |
FT. LAUDERDALE,
FL
33332
|
|
Correspondent Contact |
JOHN GREENBAUM |
Regulation Number | 870.2360
|
Classification Product Code |
|
Date Received | 07/24/2000 |
Decision Date | 08/18/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|