Device Classification Name |
electrocardiograph
|
510(k) Number |
K122632 |
Device Name |
GUAVA II |
Applicant |
CARDIOCOMM SOLUTIONS, INC. |
445 APOLLO BEACH BLVD. |
APOLLO BEACH,
FL
33572
|
|
Applicant Contact |
JONATHAN WARD |
Correspondent |
CARDIOCOMM SOLUTIONS, INC. |
445 APOLLO BEACH BLVD. |
APOLLO BEACH,
FL
33572
|
|
Correspondent Contact |
JONATHAN WARD |
Regulation Number | 870.2340
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/29/2012 |
Decision Date | 02/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|