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510(k) K151784

ActTrust by Condor Instruments Ltda. - Epp — Product Code LEL

K151784 is an FDA 510(k) premarket notification submitted by Condor Instruments Ltda. - Epp for the device "ActTrust". The FDA issued a decision of Substantially Equivalent on May 25, 2016. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2016
Date Received
July 1, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sleep Assessment
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

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FDA data resources