510(k) K190802
K190802 is an FDA 510(k) premarket notification submitted by Civco Medical Solutions for the device "Envision ultrasound pad and cover". The FDA issued a decision of Substantially Equivalent on May 24, 2019. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Civco Medical Solutions has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 2019
- Date Received
- March 29, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Transducer, Ultrasonic, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type