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510(k) K123144

VIVO 50 by Ge Healthcare, Breas Medical AB — Product Code NOU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 18, 2013
Date Received: October 5, 2012
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Continuous, Ventilator, Home Use
Device Class: Class II
Regulation Number: 868.5895
Review Panel: AN
Submission Type

This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.