Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K153479
Device Classification Name
System, Imaging, Optical Coherence Tomography (Oct)
More FDA Info for this Device
510(K) Number
K153479
Device Name
System, Imaging, Optical Coherence Tomography (Oct)
Applicant
NINEPOINT MEDICAL, INC
12 OAK PARK DRIVE
BEDFORD, MA 01730 US
Other 510(k) Applications for this Company
Contact
EMAN NAMATI
Other 510(k) Applications for this Contact
Regulation Number
892.1560
More FDA Info for this Regulation Number
Classification Product Code
NQQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/02/2015
Decision Date
02/16/2016
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact