Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K120412 |
Device Name |
3M SPOTON TEMPERATURE MONITORING SYSTEM |
Applicant |
ARIZANT HEALTHCARE INC. |
10393 WEST 70TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
DAVID WESTLIN |
Correspondent |
ARIZANT HEALTHCARE INC. |
10393 WEST 70TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
DAVID WESTLIN |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 02/10/2012 |
Decision Date | 05/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|