Mini Ridge Filter and auxiliary functions for PROBEAT-V— 510(k) K181676
Substantially EquivalentHitachi Ltd. Healthcare Hitachi Works
FDA 510(k) clearance K181676 for Mini Ridge Filter and auxiliary functions for PROBEAT-V, Substantially Equivalent on 2018-08-15. Applicant: Hitachi Ltd. Healthcare Hitachi Works.
Clearance details
- Applicant
- Hitachi Ltd. Healthcare Hitachi Works
- Product code
- Code LHN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hitachi, JP
Data sourced from openFDA. This site is unofficial and independent of the FDA.