Cleared Traditional

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

K091786 · Pulsion Medical Systems AG · Cardiovascular

Jun 2010

Decision

366d

Days

Class 2

Risk

About This 510(k) Submission

K091786 is an FDA 510(k) clearance for the PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48), a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Pulsion Medical Systems AG (Wake Forest, US). The FDA issued a Cleared decision on June 18, 2010, 366 days after receiving the submission on June 17, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number	K091786 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2009
Decision Date	June 18, 2010
Days to Decision	366 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF