AIRIS, AIRIS II— 510(k) K992650
Substantially EquivalentHitachi Medical Systems America, Inc.
FDA 510(k) clearance K992650 for AIRIS, AIRIS II, Substantially Equivalent on 1999-10-08. Applicant: Hitachi Medical Systems America, Inc.. Device class: 2.
Clearance details
- Applicant
- Hitachi Medical Systems America, Inc.
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Twinsburg, OH, US
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