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FDA 510(k)

Bite Away

K-Number: K160943 · 2016-08-26

ApplicantRiemser Pharma
Decision Date2016-08-26
Product CodeIRT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Bite Away is a medical device manufactured by Riemser Pharma. It received FDA 510(k) clearance on 2016-08-26 under approval number K160943. The device is classified under product code IRT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bite Away?

Bite Away is a medical device that received FDA 510(k) clearance on 2016-08-26. It is manufactured by Riemser Pharma. The 510(k) number is K160943.

When was Bite Away approved by the FDA?

Bite Away received FDA 510(k) clearance on 2016-08-26, under approval number K160943.

What company makes Bite Away?

Bite Away is manufactured by Riemser Pharma.

What is the FDA product code for Bite Away?

The FDA product code for Bite Away is IRT.

Related Devices (Code: IRT)

K220514bite away neomibeTec GmbH K250047bite away twomibeTec GmbH

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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