Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K152204
Device Classification Name
More FDA Info for this Device
510(K) Number
K152204
Device Name
VS3-IR system
Applicant
VISIONSENSE LTD
20 HAMAGSHIMIM ST
PETACH TIKVA, HAMERKAZ 49348 IL
Other 510(k) Applications for this Company
Contact
ALEX CHANIN
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/06/2015
Decision Date
10/28/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
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