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FDA 510(k)

MODEL 6100 AMBULATORY INFUSION SYSTEM

K-Number: K943310 · 1995-02-21

ApplicantPharmacia Deltec, Inc.
Decision Date1995-02-21
Product CodeMEA
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

MODEL 6100 AMBULATORY INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Deltec, Inc.. It received FDA 510(k) clearance on 1995-02-21 under 510(k) number K943310. The device is classified under product code MEA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the MODEL 6100 AMBULATORY INFUSION SYSTEM?

MODEL 6100 AMBULATORY INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-02-21. The listed applicant is Pharmacia Deltec, Inc.. The 510(k) number is K943310.

When did MODEL 6100 AMBULATORY INFUSION SYSTEM receive FDA 510(k) clearance?

MODEL 6100 AMBULATORY INFUSION SYSTEM received FDA 510(k) clearance on 1995-02-21, under 510(k) number K943310.

Who is the listed applicant for MODEL 6100 AMBULATORY INFUSION SYSTEM?

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

What is the FDA product code for MODEL 6100 AMBULATORY INFUSION SYSTEM?

The FDA product code for MODEL 6100 AMBULATORY INFUSION SYSTEM is MEA.

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Other records listing Pharmacia Deltec, 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.

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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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