AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE— 510(k) K032278

Substantially Equivalent

Ambu, Inc.

FDA 510(k) clearance K032278 for AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE, Substantially Equivalent on 2004-03-05. Applicant: Ambu, Inc..

Clearance details

Applicant: Ambu, Inc.
Product code: Code GXY
Advisory panel: Neurology
Date received: 2003-07-24
Decision date: 2004-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Linthicum, MD, US

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