Device Classification Name |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
|
510(k) Number |
K150992 |
Device Name |
Vios Monitoring System |
Applicant |
VIOS MEDICAL, INC. |
7300 HUDSON BLVD N, STE 140 |
ST. PAUL,
MN
55128
|
|
Applicant Contact |
MEGAN GRAHAM |
Correspondent |
VIOS MEDICAL, INC. |
7300 HUDSON BLVD N, STE 140 |
ST. PAUL,
MN
55128
|
|
Correspondent Contact |
MEGAN GRAHAM |
Regulation Number | 870.2300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/15/2015 |
Decision Date | 12/16/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|