ZAPnea Oral Appliance
K-Number: K173064 · 2019-03-08
ApplicantB. Fareid, Dds, PC
Decision Date2019-03-08
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ZAPnea Oral Appliance is a medical device manufactured by B. Fareid, Dds, PC. It received FDA 510(k) clearance on 2019-03-08 under approval 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. It is manufactured by B. Fareid, Dds, PC. The 510(k) number is K173064.
When was ZAPnea Oral Appliance approved by the FDA?
ZAPnea Oral Appliance received FDA 510(k) clearance on 2019-03-08, under approval number K173064.
What company makes ZAPnea Oral Appliance?
ZAPnea Oral Appliance is manufactured by B. Fareid, Dds, PC.
What is the FDA product code for ZAPnea Oral Appliance?
The FDA product code for ZAPnea Oral Appliance is LRK.
Related Devices (Code: LRK)
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.