FDA 510(k)

bite away neo

K-Number: K220514 · 2022-06-23

Decision Date2022-06-23

Product CodeIRT

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

bite away neo is the device name listed in this FDA 510(k) record. The listed applicant is mibeTec GmbH. It received FDA 510(k) clearance on 2022-06-23 under 510(k) number K220514. 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 neo?

bite away neo is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is mibeTec GmbH. The 510(k) number is K220514.

When did bite away neo receive FDA 510(k) clearance?

bite away neo received FDA 510(k) clearance on 2022-06-23, under 510(k) number K220514.

Who is the listed applicant for bite away neo?

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

What is the FDA product code for bite away neo?

The FDA product code for bite away neo is IRT.

Other records listing mibeTec GmbH as applicant

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 two

Related Devices (Code: IRT)

K250047bite away twomibeTec GmbH K160943Bite AwayRiemser Pharma

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.