Device Classification Name |
Calculator, Drug Dose
|
510(k) Number |
K132547 |
Device Name |
ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) |
Applicant |
MONARCH MEDICAL TECHNOLOGIES |
3457 CHISWICK COURT |
SILVER SPRING,
MD
20906
|
|
Applicant Contact |
ANN A GRAHAM |
Correspondent |
MONARCH MEDICAL TECHNOLOGIES |
3457 CHISWICK COURT |
SILVER SPRING,
MD
20906
|
|
Correspondent Contact |
ANN A GRAHAM |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 08/13/2013 |
Decision Date | 04/17/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|