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510(k) K960044

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

K960044 is an FDA 510(k) premarket notification submitted by Entlab OY for the device "ULTRAMAX/MODEL NUMBER A1". The FDA issued a decision of Substantially Equivalent on August 2, 1996. The device falls under product code LWI (Ultrasound, Sinus), a Class II device regulated under 21 CFR 892.1560.

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