FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Leva Pelvic Health System
K Number: K212495
·
Decision Sep 8, 2021
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
4
Review Days
30
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Basic Information
- Device Name
- Leva Pelvic Health System
- K Number
- K212495
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.1425
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Renovia, Inc.
- Date Received
- August 9, 2021
- Decision Date
- September 8, 2021
- Product Code
- HIR
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| HIR | Perineometer | FDA class 2 | Obstetrics/Gynecology |
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