Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K060424
Device Classification Name
Ophthalmoscope,Laser,Scanning
More FDA Info for this Device
510(K) Number
K060424
Device Name
Ophthalmoscope,Laser,Scanning
Applicant
OPTOS PLC
555 THIRTEENTH ST. N.W.
COLUMBIA SQUARE
WASHINGTON, DC 20004-1109 US
Other 510(k) Applications for this Company
Contact
HOWARD M HOLSTEIN
Other 510(k) Applications for this Contact
Regulation Number
886.1570
More FDA Info for this Regulation Number
Classification Product Code
MYC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/17/2006
Decision Date
03/17/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact