PULSION PICCO PLUS, MODEL 8100— 510(k) K060898
Substantially EquivalentPulsion Medical Systems AG
FDA 510(k) clearance K060898 for PULSION PICCO PLUS, MODEL 8100, Substantially Equivalent on 2006-07-25. Applicant: Pulsion Medical Systems AG. Device class: 2.
Clearance details
- Applicant
- Pulsion Medical Systems AG
- Product code
- Code DXG
- Device class
- Class 2
- Regulation
- 21 CFR 870.1435
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raleigh, NC, US
Recent devices under product code DXG
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- K020587 — PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046
Data sourced from openFDA. This site is unofficial and independent of the FDA.