Ambu Neuroline Single Patient Eeg/Ep Cup Electrode

FDA 510(k) K032278 · Ambu, Inc.

Substantially Equivalent

510(k) numberK032278

Submission

Device name
Ambu Neuroline Single Patient Eeg/Ep Cup Electrode
Applicant
Ambu, Inc.
Linthicum, MD, US
Received
July 24, 2003
Decision date
March 5, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GXY – Electrode, Cutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1320
Specialty
Neurology

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Questions and answers

When was Ambu Neuroline Single Patient Eeg/Ep Cup Electrode cleared by the FDA?

Ambu Neuroline Single Patient Eeg/Ep Cup Electrode (K032278) received a 510(k) decision of Substantially Equivalent on March 5, 2004, 225 days after the submission was received.

What is the product code of K032278?

The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.