MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE— 510(k) K071185

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K071185 for MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, Substantially Equivalent on 2007-05-30. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code GXZ
Advisory panel: Neurology
Date received: 2007-04-30
Decision date: 2007-05-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Glen Burnie, MD, US

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