FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
V-PVP
K Number: K232125
·
Decision Mar 20, 2024
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
253
Applicant Total
4
Review Days
247
Basic Information
- Device Name
- V-PVP
- K Number
- K232125
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VITROMED GmbH
- Date Received
- July 17, 2023
- Decision Date
- March 20, 2024
- Product Code
- MQL
- 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 |
|---|---|---|---|
| MQL | Media, Reproductive | FDA class 2 | Obstetrics/Gynecology |
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