Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K172656
Device Classification Name
Unit, Neonatal Phototherapy
More FDA Info for this Device
510(K) Number
K172656
Device Name
Unit, Neonatal Phototherapy
Applicant
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford, PA 18969 US
Other 510(k) Applications for this Company
Contact
Gale Winarsky
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
09/05/2017
Decision Date
05/01/2018
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