Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K183431 |
Device Name |
Medline Digital Rectal Thermometer Sheath |
Applicant |
Medline Industries, Inc. |
Three Lakes Drive |
Northfield,
IL
60093
|
|
Applicant Contact |
Dinah Rincones |
Correspondent |
Medline Industries, Inc. |
Three Lakes Drive |
Northfield,
IL
60093
|
|
Correspondent Contact |
Dinah Rincones |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 12/11/2018 |
Decision Date | 06/14/2019 |
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
|
|
|