AIRIS II— 510(k) K994378
Substantially EquivalentHitachi Medical Systems America, Inc.
FDA 510(k) clearance K994378 for AIRIS II, Substantially Equivalent on 2000-03-07. Applicant: Hitachi Medical Systems America, Inc..
Clearance details
- Applicant
- Hitachi Medical Systems America, Inc.
- Product code
- Code MOS
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Twinsburg, OH, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.