AiSteth®— 510(k) K252915
Substantially EquivalentAi 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.. Device class: 2.
Summary
Ai Health Highway India's AiSteth is filed under DQD, electronic stethoscopes.
Class II, 21 CFR 870.1875. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Ai Health Highway filed from Bangalore, India. Review took 252 calendar days (September 12, 2025 to May 22, 2026).
Clearance details
- Applicant
- Ai Health Highway India Pvt., Ltd.
- Product code
- Product code DQD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bangalore, IN
Recent devices under product code DQD
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