510(k) clearance
Hemotag Analysis Software (HAS)
- 510(k) number
- K252736
- Applicant
- Aventusoft, LLC
- Decision date
- Oct 21, 2026
- Date received
- Aug 28, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DQD
- Device type
- Stethoscope, Electronic
- Device class
- Class II
- Regulation
- 21 CFR 870.1875
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Boca Raton, FL, US