Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K143267 |
Device Name |
TempTraq TT-100 |
Applicant |
Blue Spark Technologies Inc. |
806 Sharon Drive, Suite G |
Westlake,
OH
44145
|
|
Applicant Contact |
Jennifer Cartledge |
Correspondent |
REU Associates Inc. |
409 Woodridge Dr. |
Seneca,
SC
29672
|
|
Correspondent Contact |
Jennifer Cartledge |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 11/13/2014 |
Decision Date | 09/02/2015 |
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
|
|
|