AHI System— 510(k) K221203

Substantially Equivalent

Fifth Eye, Inc.

FDA 510(k) clearance K221203 for AHI System, Substantially Equivalent on 2022-07-14. Applicant: Fifth Eye, Inc..

Clearance details

Applicant: Fifth Eye, Inc.
Product code: Code QNV
Advisory panel: Cardiovascular
Date received: 2022-04-26
Decision date: 2022-07-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Ann Arbor, MI, US

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