Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K150869 |
Device Name |
Checkme Pro Health Monitor |
Applicant |
Viatom Technology Co., Ltd. |
C607,Languang Park, No. 7 Xinxi Road |
Hi-Tech Park( north) |
Nanshan, Shenzhen,
CN
518057
|
|
Applicant Contact |
Zhou Saixin |
Correspondent |
Biologics Consulting Group, Inc. |
400 N. Washington St. Suite 100 |
Alexandria,
VA
22314
|
|
Correspondent Contact |
Donna-Bea Tillman |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 04/01/2015 |
Decision Date | 12/10/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|