MEDLEY PCA MODULE, MODEL 8120

Pump, Infusion, Pca

ALARIS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Alaris Medical Systems, Inc. with the FDA for Medley Pca Module, Model 8120.

Pre-market Notification Details

• Device ID: K043299
• 510k Number: K043299
• Device Name: MEDLEY PCA MODULE, MODEL 8120
• Classification: Pump, Infusion, Pca
• Applicant: ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121
• Contact: Stacy L Lewis
• Correspondent: Stacy L Lewis; ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121
• Product Code: MEA
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-11-30
• Decision Date: 2004-12-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10885403494291	K043299	000
10885403812002	K043299	000