FemDx FalloView— 510(k) K221965
Substantially EquivalentFemdx Medsystems, Inc.
FDA 510(k) clearance K221965 for FemDx FalloView, Substantially Equivalent on 2023-03-17. Applicant: Femdx Medsystems, Inc.. Device class: 2.
Clearance details
- Applicant
- Femdx Medsystems, Inc.
- Product code
- Code MKO
- Device class
- Class 2
- Regulation
- 21 CFR 884.1690
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Recent devices under product code MKO
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