PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)— 510(k) K091786

Name: FDA 510(k) clearance K091786
Creator: U.S. Food and Drug Administration
Published: 2010-06-18

Substantially Equivalent

Pulsion Medical Systems AG

FDA 510(k) clearance K091786 for PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48), Substantially Equivalent on 2010-06-18. 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: 2009-06-17
Decision date: 2010-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wake Forest, NC, US

Download summary PDF View on FDA.gov ↗

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