FRESENIUS ICARE MONITORING SYSTEM— 510(k) K021060
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K021060 for FRESENIUS ICARE MONITORING SYSTEM, Substantially Equivalent on 2002-11-13. Applicant: Fresenius Medical Care North America. Device class: 2.
Clearance details
- Applicant
- Fresenius Medical Care North America
- Product code
- Code FKP
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, MA, US
Recent devices under product code FKP
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