Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K180131
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K180131
Device Name
Thermometer, Electronic, Clinical
Applicant
Kaz USA, Inc., A Helen of Troy Company
400 Donald Lynch Boulevard, Suite 300
Marlborough, MA 01752 US
Other 510(k) Applications for this Company
Contact
Matt J. Baun
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
01/17/2018
Decision Date
08/14/2018
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