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FDA 510(k)

Byteflies Kit

K-Number: K192549 · 2020-06-22

ApplicantByteflies NV
Decision Date2020-06-22
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Byteflies Kit is a medical device manufactured by Byteflies NV. It received FDA 510(k) clearance on 2020-06-22 under approval 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. It is manufactured by Byteflies NV. The 510(k) number is K192549.

When was Byteflies Kit approved by the FDA?

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

What company makes Byteflies Kit?

Byteflies Kit is manufactured by Byteflies NV.

What is the FDA product code for Byteflies Kit?

The FDA product code for Byteflies Kit is OMC.

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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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