Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K071175
Device Classification Name
Incubator, Neonatal
More FDA Info for this Device
510(K) Number
K071175
Device Name
Incubator, Neonatal
Applicant
GE HEALTHCARE
8880 GORMAN RD
LAUREL, MD 20723 US
Other 510(k) Applications for this Company
Contact
AGATA SMIEJA
Other 510(k) Applications for this Contact
Regulation Number
880.5400
More FDA Info for this Regulation Number
Classification Product Code
FMZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/27/2007
Decision Date
07/17/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact