510(k) K173553

LUCAS 3 Chest Compression System by Jolife AB — Product Code DRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2018
Date Received
November 16, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Cardiac, External
Device Class
Class II
Regulation Number
870.5200
Review Panel
CV
Submission Type