Da Vinchi Emg/Ep ISA1004EP
FDA 510(k) K001467 · Airsep Corp.
510(k) numberK001467
Submission
- Device name
- Da Vinchi Emg/Ep ISA1004EP
- Applicant
- Airsep Corp.
Buffalo, NY, US - Received
- May 10, 2000
- Decision date
- August 1, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K000963 | Da Vinchi EEG and Emg/Ep SystemsGWF · Traditional | 10/20/2000SE |
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| K001013 | Monet Acquisition System for EEG and PolysomnographyOLV · Traditional | 05/16/2000SE |
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Questions and answers
When was Da Vinchi Emg/Ep ISA1004EP cleared by the FDA?
Da Vinchi Emg/Ep ISA1004EP (K001467) received a 510(k) decision of Substantially Equivalent on August 1, 2000, 83 days after the submission was received.
What is the product code of K001467?
The FDA product code is GWE – Stimulator, Photic, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1890.