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FDA 510(k)

Phasor Drill

K-Number: K161704 · 2016-12-01

ApplicantBiotex, Inc.
Decision Date2016-12-01
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Phasor Drill is a medical device manufactured by Biotex, Inc.. It received FDA 510(k) clearance on 2016-12-01 under approval number K161704. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Phasor Drill?

Phasor Drill is a medical device that received FDA 510(k) clearance on 2016-12-01. It is manufactured by Biotex, Inc.. The 510(k) number is K161704.

When was Phasor Drill approved by the FDA?

Phasor Drill received FDA 510(k) clearance on 2016-12-01, under approval number K161704.

What company makes Phasor Drill?

Phasor Drill is manufactured by Biotex, Inc..

What is the FDA product code for Phasor Drill?

The FDA product code for Phasor Drill is HBE.

Other Devices by Biotex, Inc.

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Related Devices (Code: HBE)

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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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