VitriGuard— 510(k) K180740
Substantially EquivalentOrigio A/S
FDA 510(k) clearance K180740 for VitriGuard, Substantially Equivalent on 2018-05-04. Applicant: Origio A/S. Device class: 2.
Clearance details
- Applicant
- Origio A/S
- Product code
- Code MQK
- Device class
- Class 2
- Regulation
- 21 CFR 884.6160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Måløv, DK
Recent devices under product code MQK
view all- K241626 — SperSort Sperm Sorting Chip (IPG02)
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- K241348 — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
- K241341 — cryo-GO Vitrification Device
- K240002 — G-Vitri Vitrification Straw
More clearances from Origio A/S
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