Modification to: Ambu Neuroline, Disposable Monopolar Needle Electrode
FDA 510(k) K071185 · Ambu A/S
510(k) numberK071185
Submission
- Device name
- Modification to: Ambu Neuroline, Disposable Monopolar Needle Electrode
- Applicant
- Ambu A/S
Glen Burnie, MD, US - Received
- April 30, 2007
- Decision date
- May 30, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Modification to: Ambu Neuroline, Disposable Monopolar Needle Electrode cleared by the FDA?
Modification to: Ambu Neuroline, Disposable Monopolar Needle Electrode (K071185) received a 510(k) decision of Substantially Equivalent on May 30, 2007, 30 days after the submission was received.
What is the product code of K071185?
The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.