Invu by Nuvo
FDA 510(k) clearance K221046 · decided 2022-05-06
Clearance details
- K-number
- K221046
- Device name
- Invu by Nuvo
- Applicant
- Nuvo- Group , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-08
- Decision date
- 2022-05-06
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LQK
- Device class
- 2
- Regulation number
- 884.2730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Tel Aviv, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INVU by Nuvo (K210025) | Nuvo- Group , Ltd. | 2021-05-28 |
| PregSense (K191401) | Nuvo- Group , Ltd. | 2020-03-27 |
| Sense4Baby System Model B+ (MSA) (K143114) | Airstrip Technologies, Inc. | 2015-03-10 |
| MODIFICATION TO FETAL ASSIST (K020390) | Huntleigh Diagnostics , Ltd. | 2002-04-19 |
Recalls involving this device
No recalls on record reference this clearance.