AHI System— 510(k) K212219

Substantially Equivalent

Fifth Eye, Inc.

FDA 510(k) clearance K212219 for AHI System, Substantially Equivalent on 2021-12-03. Applicant: Fifth Eye, Inc..

Clearance details

Applicant: Fifth Eye, Inc.
Product code: Code QNV
Advisory panel: Cardiovascular
Date received: 2021-07-16
Decision date: 2021-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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