Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K161728
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K161728
Device Name
Thermometer, Electronic, Clinical
Applicant
MICROFILE INTELLECTUAL PROPERTY GMBH
ESPENSTRASSE 139
WIDNAU 9443 CH
Other 510(k) Applications for this Company
Contact
GERHARD FRICK
Other 510(k) Applications for this Contact
Regulation Number
880.2910
More FDA Info for this Regulation Number
Classification Product Code
FLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/22/2016
Decision Date
12/05/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact