FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
AiSteth®
K Number: K252915
·
Decision May 22, 2026
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
1
Review Days
252
Basic Information
- Device Name
- AiSteth®
- K Number
- K252915
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ai Health Highway India Pvt., Ltd.
- Date Received
- September 12, 2025
- Decision Date
- May 22, 2026
- Product Code
- DQD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQD | Stethoscope, Electronic | FDA class 2 | Cardiovascular |
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