510(k) K191491
K191491 is an FDA 510(k) premarket notification submitted by Medxpress.Pro for the device "EZ-Cover". The FDA issued a decision of Substantially Equivalent on Jun 5, 2020. 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
- Jun 5, 2020
- Date Received
- Jun 5, 2019
- 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
- 510(k)