CARDIOMATCH— 510(k) K970970
Substantially EquivalentFocus Medical SA
FDA 510(k) clearance K970970 for CARDIOMATCH, Substantially Equivalent on 1997-06-13. Applicant: Focus Medical SA. Device class: 2.
Clearance details
- Applicant
- Focus Medical SA
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wellesley, MA, US
Recent devices under product code KPS
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