Device Classification Name |
electrocardiograph
|
510(k) Number |
K152135 |
Device Name |
Quantitative Electrocardiographic Detector (QED 2000) |
Applicant |
ACME Portable Machines, Inc. |
1330 Mountain View Circle |
azusa,
CA
91702
|
|
Applicant Contact |
james cheng |
Correspondent |
ACME Portable Machines, Inc. |
1330 Mountain View Circle |
azusa,
CA
91702
|
|
Correspondent Contact |
james cheng |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 07/31/2015 |
Decision Date | 08/09/2016 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|