Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K102063 |
Device Name |
HEALTH-E-CONNECT SYSTEM |
Applicant |
ALR TECHNOLOGIES |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
ALR TECHNOLOGIES |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/23/2010 |
Decision Date | 10/11/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|