FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Invu by Nuvo
K Number: K221046
·
Decision May 6, 2022
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- Invu by Nuvo
- K Number
- K221046
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.2730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nuvo- Group , Ltd.
- Date Received
- April 8, 2022
- Decision Date
- May 6, 2022
- Product Code
- LQK
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LQK | Home Uterine Activity Monitor | FDA class 2 | Obstetrics/Gynecology |
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