ZAPnea Oral Appliance— 510(k) K173064

Substantially Equivalent

B. Fareid, Dds, PC

FDA 510(k) clearance K173064 for ZAPnea Oral Appliance, Substantially Equivalent on 2019-03-08. Applicant: B. Fareid, Dds, PC.

Clearance details

Applicant: B. Fareid, Dds, PC
Product code: Code LRK
Advisory panel: Dental
Date received: 2017-09-29
Decision date: 2019-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingsburg, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.