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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 the device name listed in this FDA 510(k) record. The listed applicant is Riemser Pharma. It received FDA 510(k) clearance on 2016-08-26 under 510(k) 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. The listed applicant is Riemser Pharma. The 510(k) number is K160943.

When did Bite Away receive FDA 510(k) clearance?

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

Who is the listed applicant for Bite Away?

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

What is the FDA product code for Bite Away?

The FDA product code for Bite Away is IRT.

Related Devices (Code: IRT)

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.

K250047bite away twomibeTec GmbHK220514bite away neomibeTec GmbH

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.

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