Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K153335 |
Device Name |
AlertWatch: OR |
Applicant |
ALERTWATCH LLC |
1600 HURON PARKWAY, BLDG. 520, STE. 2326 |
ANN ARBOR,
MI
48109
|
|
Applicant Contact |
Justin Adams |
Correspondent |
BIOLOGICS CONSULTING GROUP, INC. |
400 N. WASHINGTON STREET |
SUITE 100 |
ALEXANDRIA,
VA
22314
|
|
Correspondent Contact |
Donna-Bea Tillman |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 11/19/2015 |
Decision Date | 03/15/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|