Device Classification Name |
calculator, drug dose
|
510(k) Number |
K163664 |
Device Name |
Health-e-Connect System with IDA |
Applicant |
ALR TECHNOLOGIES |
7400 BEAUFONT SPRINGS DRIVE, SUITE 300 |
RICHMOND,
VA
23225
|
|
Applicant Contact |
SIDNEY CHAN |
Correspondent |
ALR TECHNOLOGIES |
7400 BEAUFONT SPRINGS DRIVE, SUITE 300 |
RICHMOND,
VA
23225
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 12/27/2016 |
Decision Date | 09/18/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|