510(k) K252736
K252736 is an FDA 510(k) premarket notification submitted by Aventusoft, LLC for the device "Hemotag Analysis Software (HAS)". The FDA issued a decision of Substantially Equivalent on Oct 21, 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
- Oct 21, 2026
- Date Received
- Aug 28, 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
- 510(k)