510(k) K241671
K241671 is an FDA 510(k) premarket notification submitted by Esaote, S.p.A. for the device "6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)". The FDA issued a decision of Substantially Equivalent on May 16, 2025. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Esaote, S.p.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2025
- Date Received
- June 11, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type