Device Classification Name |
calculator, drug dose
|
510(k) Number |
K061110 |
Device Name |
GLUCOMMANDER PLUS |
Applicant |
COLLABORATIVEMED, LLC |
14-D PELHAM RIDGE DRIVE |
GREENVILLE,
SC
29615
|
|
Applicant Contact |
ROBERT BOOTH |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
CAMAS,
WA
98607 -9526
|
|
Correspondent Contact |
MARC M MOUSER |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 04/20/2006 |
Decision Date | 06/07/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|