FDA 510(k)

ZAPnea Oral Appliance

K-Number: K173064 · 2019-03-08

Decision Date2019-03-08

Product CodeLRK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ZAPnea Oral Appliance is the device name listed in this FDA 510(k) record. The listed applicant is B. Fareid, Dds, PC. It received FDA 510(k) clearance on 2019-03-08 under 510(k) number K173064. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZAPnea Oral Appliance?

ZAPnea Oral Appliance is a medical device that received FDA 510(k) clearance on 2019-03-08. The listed applicant is B. Fareid, Dds, PC. The 510(k) number is K173064.

When did ZAPnea Oral Appliance receive FDA 510(k) clearance?

ZAPnea Oral Appliance received FDA 510(k) clearance on 2019-03-08, under 510(k) number K173064.

Who is the listed applicant for ZAPnea Oral Appliance?

The FDA 510(k) record lists B. Fareid, Dds, PC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZAPnea Oral Appliance?

The FDA product code for ZAPnea Oral Appliance is LRK.

Related Devices (Code: LRK)

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.

K261912SnØreNegatØrDnB Innovations, LLC K261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLC K261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC K253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

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.