510(k) K192270
K192270 is an FDA 510(k) premarket notification submitted by Renovia, Inc. for the device "LEva Pelvic Digital Health System". The FDA issued a decision of Substantially Equivalent on November 22, 2019. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Renovia, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2019
- Date Received
- August 22, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Perineometer
- Device Class
- Class II
- Regulation Number
- 884.1425
- Review Panel
- GU
- Submission Type