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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K091786
Device Name PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)
Applicant
Pulsion Medical Systems AG
7220 Sparhawk Rd.
Wake Forest,  NC  27587
Applicant Contact Jamie Sulley
Correspondent
Pulsion Medical Systems AG
7220 Sparhawk Rd.
Wake Forest,  NC  27587
Correspondent Contact Jamie Sulley
Regulation Number870.1435
Classification Product Code
DXG  
Date Received06/17/2009
Decision Date 06/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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