AiSteth®— 510(k) K252915

Substantially Equivalent

Ai Health Highway India Pvt., Ltd.

FDA 510(k) clearance K252915 for AiSteth®, Substantially Equivalent on 2026-05-22. Applicant: Ai Health Highway India Pvt., Ltd..

Clearance details

Applicant
Ai Health Highway India Pvt., Ltd.
Product code
Code DQD
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bangalore, IN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.