FDA 510(k)

CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0

K-Number: K130394 · 2013-12-09

Decision Date2013-12-09

Product CodeMEA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2013-12-09 under 510(k) number K130394. 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 CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0?

CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 is a medical device that received FDA 510(k) clearance on 2013-12-09. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K130394.

When did CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 receive FDA 510(k) clearance?

CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 received FDA 510(k) clearance on 2013-12-09, under 510(k) number K130394.

Who is the listed applicant for CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0?

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

What is the FDA product code for CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0?

The FDA product code for CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 is MEA.

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Related Devices (Code: MEA)

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.K092313PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEMB.Braun Medical, Inc.K072144CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATORSmiths Medical MD, Inc.K051253MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)Baxter Healthcare Corp

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.