Home / 510(k) Clearances / K960044

510(k) K960044

ULTRAMAX/MODEL NUMBER A1 by Entlab OY — Product Code LWI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 2, 1996
Date Received: January 2, 1996
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Ultrasound, Sinus
Device Class: Class II
Regulation Number: 892.1560
Review Panel: EN
Submission Type