Orion— 510(k) K200529

Substantially Equivalent

Interacoustics A/S

FDA 510(k) clearance K200529 for Orion, Substantially Equivalent on 2020-08-12. Applicant: Interacoustics A/S.

Clearance details

Applicant: Interacoustics A/S
Product code: Code LXV
Advisory panel: Unknown
Date received: 2020-03-02
Decision date: 2020-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middelfart, DK

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