Da Vinchi EEG and Emg/Ep Systems
FDA 510(k) K000963 · Airsep Corp.
510(k) numberK000963
Submission
- Device name
- Da Vinchi EEG and Emg/Ep Systems
- Applicant
- Airsep Corp.
Buffalo, NY, US - Received
- March 24, 2000
- Decision date
- October 20, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Da Vinchi EEG and Emg/Ep Systems cleared by the FDA?
Da Vinchi EEG and Emg/Ep Systems (K000963) received a 510(k) decision of Substantially Equivalent on October 20, 2000, 210 days after the submission was received.
What is the product code of K000963?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.