PULSION PICCO-2, MODEL 8500— 510(k) K072735
Substantially EquivalentPulsion Medical Systems AG
FDA 510(k) clearance K072735 for PULSION PICCO-2, MODEL 8500, Substantially Equivalent on 2007-10-18. 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
- Special
- Location
- Wake Forest, NC, US
Recent devices under product code DXG
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view all- K091786 — PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)
- K072364 — PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
- K060898 — PULSION PICCO PLUS, MODEL 8100
- 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.