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FDA 510(k)

MEDLEY PCA MODULE, MODEL 8120

K-Number: K043299 · 2004-12-10

ApplicantAlaris Medical Systems, Inc.
Decision Date2004-12-10
Product CodeMEA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDLEY PCA MODULE, MODEL 8120 is the device name listed in this FDA 510(k) record. The listed applicant is Alaris Medical Systems, Inc.. It received FDA 510(k) clearance on 2004-12-10 under 510(k) number K043299. The device is classified under product code MEA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDLEY PCA MODULE, MODEL 8120?

MEDLEY PCA MODULE, MODEL 8120 is a medical device that received FDA 510(k) clearance on 2004-12-10. The listed applicant is Alaris Medical Systems, Inc.. The 510(k) number is K043299.

When did MEDLEY PCA MODULE, MODEL 8120 receive FDA 510(k) clearance?

MEDLEY PCA MODULE, MODEL 8120 received FDA 510(k) clearance on 2004-12-10, under 510(k) number K043299.

Who is the listed applicant for MEDLEY PCA MODULE, MODEL 8120?

The FDA 510(k) record lists Alaris Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDLEY PCA MODULE, MODEL 8120?

The FDA product code for MEDLEY PCA MODULE, MODEL 8120 is MEA.

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Other records listing Alaris Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K041241MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600K031741MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300K032233MEDLEY PCA MODULE, MODEL 8120K032147SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIESK030459MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)K023264MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110

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Related Devices (Code: MEA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc.K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)Smiths Medical Ads, Inc.K143612LifeCare PCA Infusion SystemHospira, Inc.K130394CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0Smiths Medical Asd, Inc.K092313PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEMB.Braun Medical, Inc.K072144CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATORSmiths Medical MD, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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