FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEva Pelvic Digital Health System
K Number: K192270
·
Decision Nov 22, 2019
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
4
Review Days
92
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Basic Information
- Device Name
- LEva Pelvic Digital Health System
- K Number
- K192270
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1425
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Renovia, Inc.
- Date Received
- August 22, 2019
- Decision Date
- November 22, 2019
- Product Code
- HIR
- 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 |
|---|---|---|---|
| HIR | Perineometer | FDA class 2 | Obstetrics/Gynecology |
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