PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM— 510(k) K001762

Name: FDA 510(k) clearance K001762
Creator: U.S. Food and Drug Administration
Published: 2000-06-13

Substantially Equivalent

Pulsion Medical Systems, Inc.

FDA 510(k) clearance K001762 for PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM, Substantially Equivalent on 2000-06-13. Applicant: Pulsion Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pulsion Medical Systems, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2000-06-09
Decision date: 2000-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cornelius, NC, US

Download summary PDF View on FDA.gov ↗

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