510(k) K123216

AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN by Aimago SA — Product Code DPT

K123216 is an FDA 510(k) premarket notification submitted by Aimago SA for the device "AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN". The FDA issued a decision of Substantially Equivalent on February 7, 2013. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Aimago SA has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2013
Date Received
October 15, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Blood-Flow, Extravascular
Device Class
Class II
Regulation Number
870.2120
Review Panel
CV
Submission Type