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510(k) K141136

LEICA FL800 by Leica Biosystems Richmond — Product Code IZI

K141136 is an FDA 510(k) premarket notification submitted by Leica Biosystems Richmond for the device "LEICA FL800". The FDA issued a decision of Substantially Equivalent on August 19, 2014. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2014
Date Received
May 1, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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FDA data resources