Device Classification Name |
Electrocardiograph
|
510(k) Number |
K142693 |
Device Name |
ZywieAI Software Library |
Applicant |
Zywie, Inc. |
12000 Findley Road, Suite 360 |
Johns Creek,
GA
30097
|
|
Applicant Contact |
Latha Ganeshan |
Correspondent |
AJW TECHNOLOGY CONSULTANTS, INC. |
445 APOLLO BEACH BLVD. |
APOLLO BEACH,
FL
33572
|
|
Correspondent Contact |
Jon Ward |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 09/22/2014 |
Decision Date | 02/20/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|