INFANT CARDIAC ARRAY— 510(k) K083539
Substantially EquivalentAdvanced Imaging Research, Inc.
FDA 510(k) clearance K083539 for INFANT CARDIAC ARRAY, Substantially Equivalent on 2009-04-03. Applicant: Advanced Imaging Research, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Imaging Research, 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
- Cleveland, OH, US
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