510(k) K254143
K254143 is an FDA 510(k) premarket notification submitted by EM-TECH Solutions, Inc. for the device "EM-TECH Passive Ultrasound Probe Strap". The FDA issued a decision of Substantially Equivalent on August 10, 2026. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2026
- Date Received
- December 22, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Ultrasonic, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type