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.
Clearance details
- Applicant
- Ai Health Highway India Pvt., Ltd.
- Product code
- 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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