FLOW-DIRECTED THERMODILUTION CATHETER— 510(k) K812800
Substantially EquivalentSorensen Research
FDA 510(k) clearance K812800 for FLOW-DIRECTED THERMODILUTION CATHETER, Substantially Equivalent on 1981-10-20. Applicant: Sorensen Research. Device class: 2.
Clearance details
- Applicant
- Sorensen Research
- Product code
- Code KRB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1915
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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More clearances from Sorensen Research
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