Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K160091 |
Device Name |
Temperature Probe, Affinity Temperature Probe |
Applicant |
Medtronic, Inc. |
7611 Northland Dr. |
Brooklyn Park,
MN
55428
|
|
Applicant Contact |
Choua Thao |
Correspondent |
Medtronic, Inc. |
7611 Northland Dr. |
Brooklyn Park,
MN
55428
|
|
Correspondent Contact |
Choua Thao |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 01/15/2016 |
Decision Date | 05/20/2016 |
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
|
|
|