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FDA 510(k)

Comby EEG Caps

K-Number: K211315 · 2021-11-09

ApplicantPamel D.O.O
Decision Date2021-11-09
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Comby EEG Caps is a medical device manufactured by Pamel D.O.O. It received FDA 510(k) clearance on 2021-11-09 under approval number K211315. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Comby EEG Caps?

Comby EEG Caps is a medical device that received FDA 510(k) clearance on 2021-11-09. It is manufactured by Pamel D.O.O. The 510(k) number is K211315.

When was Comby EEG Caps approved by the FDA?

Comby EEG Caps received FDA 510(k) clearance on 2021-11-09, under approval number K211315.

What company makes Comby EEG Caps?

Comby EEG Caps is manufactured by Pamel D.O.O.

What is the FDA product code for Comby EEG Caps?

The FDA product code for Comby EEG Caps is GXY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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