Cns-Ep System and Ep 1.0 Software
FDA 510(k) K860240 · Cns, Inc.
510(k) numberK860240
Submission
- Device name
- Cns-Ep System and Ep 1.0 Software
- Applicant
- Cns, Inc.
Eden Prairie, MN, US - Received
- January 23, 1986
- Decision date
- April 17, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K950273 | Sleep Test(Tm)MNR · Traditional | 09/19/1995SE |
| K921220 | Breathe RightLWF · Traditional | 10/07/1993SE |
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| K910452 | Respi-Pak Rt-PakBZG · Traditional | 04/16/1991SE |
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Questions and answers
When was Cns-Ep System and Ep 1.0 Software cleared by the FDA?
Cns-Ep System and Ep 1.0 Software (K860240) received a 510(k) decision of Substantially Equivalent on April 17, 1986, 84 days after the submission was received.
What is the product code of K860240?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.