510(k) K252915
K252915 is an FDA 510(k) premarket notification submitted by Ai Health Highway India Pvt., Ltd. for the device "AiSteth®". The FDA issued a decision of Substantially Equivalent on May 22, 2026. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2026
- Date Received
- September 12, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Electronic
- Device Class
- Class II
- Regulation Number
- 870.1875
- Review Panel
- CV
- Submission Type