AirRay Subdural Cortical Electrodes

FDA 510(k) K183437 · Cortec GmbH

Substantially Equivalent

510(k) numberK183437

Submission

Device name
AirRay Subdural Cortical Electrodes
Applicant
Cortec GmbH
Freiburg, DE
Received
December 12, 2018
Decision date
March 12, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GYC – Electrode, Cortical
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1310
Specialty
Neurology

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Questions and answers

When was AirRay Subdural Cortical Electrodes cleared by the FDA?

AirRay Subdural Cortical Electrodes (K183437) received a 510(k) decision of Substantially Equivalent on March 12, 2019, 90 days after the submission was received.

What is the product code of K183437?

The FDA product code is GYC – Electrode, Cortical, a Class II (moderate risk) device regulated under 21 CFR 882.1310.