K252915
- 510(k) number
- K252915
- Device name
- AiSteth®
- Applicant
- Ai Health Highway India Pvt., Ltd. IN
- Product code
- DQD — Stethoscope, Electronic
- Decision date
- 2026-05-22
- Date received
- 2025-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252915.pdf
Official FDA record: K252915
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.