PROBEAT— 510(k) K053280
Substantially EquivalentHitachi, Ltd., Power Systems Group
FDA 510(k) clearance K053280 for PROBEAT, Substantially Equivalent on 2006-03-09. Applicant: Hitachi, Ltd., Power Systems Group.
Clearance details
- Applicant
- Hitachi, Ltd., Power Systems Group
- Product code
- Code LHN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.