Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K160238
Device Classification Name
Unit, Neonatal Phototherapy
More FDA Info for this Device
510(K) Number
K160238
Device Name
Unit, Neonatal Phototherapy
Applicant
INTERNATIONAL BIOMEDICAL
8206 CROSS PARK DR.
AUSTIN, TX 78754 US
Other 510(k) Applications for this Company
Contact
Amy Pieper
Other 510(k) Applications for this Contact
Regulation Number
880.5700
More FDA Info for this Regulation Number
Classification Product Code
LBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/01/2016
Decision Date
06/14/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact