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FDA 510(k)

WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts

K-Number: K162460 · 2017-04-28

ApplicantWavi Co.
Decision Date2017-04-28
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts is the device name listed in this FDA 510(k) record. The listed applicant is Wavi Co.. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K162460. 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 WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts?

WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Wavi Co.. The 510(k) number is K162460.

When did WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts receive FDA 510(k) clearance?

WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts received FDA 510(k) clearance on 2017-04-28, under 510(k) number K162460.

Who is the listed applicant for WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts?

The FDA 510(k) record lists Wavi Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts?

The FDA product code for WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts is GXY.

Other records listing Wavi Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213900WAVi SCAN EEG System and Accessories

Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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