MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

ALARIS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Alaris Medical Systems, Inc. with the FDA for Medley Etco2 Module (includes Accessories), Model 8300.

Pre-market Notification Details

• Device ID: K031741
• 510k Number: K031741
• Device Name: MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
• Classification: Analyzer, Gas, Carbon-dioxide, Gaseous-phase
• Applicant: ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121
• Contact: Renee L Fluet
• Correspondent: Renee L Fluet; ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121
• Product Code: CCK
• CFR Regulation Number: 868.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-06-04
• Decision Date: 2004-02-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10885403830013	K031741	000