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FDA 510(k)

CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300

K-Number: K982839 · 1998-11-02

ApplicantSims Deltec, Inc.
Decision Date1998-11-02
Product CodeMEA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 is the device name listed in this FDA 510(k) record. The listed applicant is Sims Deltec, Inc.. It received FDA 510(k) clearance on 1998-11-02 under 510(k) number K982839. 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-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300?

CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 is a medical device that received FDA 510(k) clearance on 1998-11-02. The listed applicant is Sims Deltec, Inc.. The 510(k) number is K982839.

When did CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 receive FDA 510(k) clearance?

CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 received FDA 510(k) clearance on 1998-11-02, under 510(k) number K982839.

Who is the listed applicant for CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300?

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

What is the FDA product code for CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300?

The FDA product code for CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 is MEA.

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Other records listing Sims Deltec, Inc. as applicant

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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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