FDA 510(k)

Byteflies Kit

K-Number: K192549 · 2020-06-22

Decision Date2020-06-22

Product CodeOMC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Byteflies Kit is the device name listed in this FDA 510(k) record. The listed applicant is Byteflies NV. It received FDA 510(k) clearance on 2020-06-22 under 510(k) number K192549. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Byteflies Kit?

Byteflies Kit is a medical device that received FDA 510(k) clearance on 2020-06-22. The listed applicant is Byteflies NV. The 510(k) number is K192549.

When did Byteflies Kit receive FDA 510(k) clearance?

Byteflies Kit received FDA 510(k) clearance on 2020-06-22, under 510(k) number K192549.

Who is the listed applicant for Byteflies Kit?

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

What is the FDA product code for Byteflies Kit?

The FDA product code for Byteflies Kit is OMC.

Related Devices (Code: OMC)

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.

K261101Ceribell MonitorCeribell, Inc.K251550NX01 (NX01)Naox Technologies Sas K251726SignalNED System (Model RE)Forest Devices, Inc.K243185REMI Remote EEG Monitoring SystemEpitel K242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K232779QUEX ED; QUEX SQx World, Ltd.

Official Source

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