510(k) K201425
K201425 is an FDA 510(k) premarket notification submitted by Huntleigh Healthcare Limited for the device "Disposable Intraoperative Probe (DIOP8)". The FDA issued a decision of Substantially Equivalent on Feb 19, 2021. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Huntleigh Healthcare Limited has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 19, 2021
- Date Received
- May 29, 2020
- 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