THE GYNOCULAR— 510(k) K132423
Substantially EquivalentGynius AB
FDA 510(k) clearance K132423 for THE GYNOCULAR, Substantially Equivalent on 2014-04-08. Applicant: Gynius AB. Device class: 2.
Clearance details
- Applicant
- Gynius AB
- Product code
- Code HEX
- Device class
- Class 2
- Regulation
- 21 CFR 884.1630
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
Recent devices under product code HEX
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