510(k) K231780
K231780 is an FDA 510(k) premarket notification submitted by X6 Innovations for the device "Perifit Care+". The FDA issued a decision of Substantially Equivalent on December 20, 2023. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. X6 Innovations has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2023
- Date Received
- June 16, 2023
- 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