PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE— 510(k) K122121

Name: FDA 510(k) clearance K122121
Creator: U.S. Food and Drug Administration
Published: 2012-08-02

Substantially Equivalent

Pulsion Medical Systems SE

FDA 510(k) clearance K122121 for PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE, Substantially Equivalent on 2012-08-02. Applicant: Pulsion Medical Systems SE. Device class: 2.

Clearance details

Applicant: Pulsion Medical Systems SE
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2012-07-17
Decision date: 2012-08-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Westbrook, CT, US

Download summary PDF View on FDA.gov ↗

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