Bunkerhill Abdominal Aortic Quantification (AAQ)— 510(k) K243779
Substantially EquivalentBunkerHill Health
FDA 510(k) clearance K243779 for Bunkerhill Abdominal Aortic Quantification (AAQ), Substantially Equivalent on 2025-07-01. Applicant: BunkerHill Health. Device class: 2.
Clearance details
- Applicant
- BunkerHill Health
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
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