Device Classification Name |
electrocardiograph
|
510(k) Number |
K011436 |
Device Name |
MOBILE-PATIENT VIEWER |
Applicant |
DATA CRITICAL CORPORATION |
15222 DEL AMO AVE. |
TUSTIN,
CA
92780
|
|
Applicant Contact |
FLORIN TRUUVERT |
Correspondent |
DATA CRITICAL CORPORATION |
15222 DEL AMO AVE. |
TUSTIN,
CA
92780
|
|
Correspondent Contact |
FLORIN TRUUVERT |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 05/10/2001 |
Decision Date | 07/05/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|