510(k) K221046
K221046 is an FDA 510(k) premarket notification submitted by Nuvo- Group , Ltd. for the device "Invu by Nuvo". The FDA issued a decision of Substantially Equivalent on May 6, 2022. The device falls under product code LQK (Home Uterine Activity Monitor), a Class II device regulated under 21 CFR 884.2730. Nuvo- Group , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2022
- Date Received
- April 8, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Home Uterine Activity Monitor
- Device Class
- Class II
- Regulation Number
- 884.2730
- Review Panel
- OB
- Submission Type