LaserShot M, NaviLase— 510(k) K192008
Substantially EquivalentVitrolife GmbH
FDA 510(k) clearance K192008 for LaserShot M, NaviLase, Substantially Equivalent on 2020-03-25. Applicant: Vitrolife GmbH. Device class: 2.
Clearance details
- Applicant
- Vitrolife GmbH
- Product code
- Code MRX
- Device class
- Class 2
- Regulation
- 21 CFR 884.6200
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Bruckberg, DE
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Data sourced from openFDA. This site is unofficial and independent of the FDA.