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FDA 510(k)

MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A

K-Number: K844792 · 1985-01-22

ApplicantPacesetter Systems
Decision Date1985-01-22
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter Systems. It received FDA 510(k) clearance on 1985-01-22 under 510(k) number K844792. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A?

MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A is a medical device that received FDA 510(k) clearance on 1985-01-22. The listed applicant is Pacesetter Systems. The 510(k) number is K844792.

When did MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A receive FDA 510(k) clearance?

MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A received FDA 510(k) clearance on 1985-01-22, under 510(k) number K844792.

Who is the listed applicant for MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A?

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

What is the FDA product code for MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A?

The FDA product code for MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A is FRN.

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Other records listing Pacesetter Systems as applicant

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K910924ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONEK902147ENDOCARDIAL SCREW-IN LEAD MODEL 1028TK900512SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERSK900550FAST-PASS ACE MODELS 1212T/1222T/1216T/1226TK895447ENDOCARDIAL SCREW-IN LEAD MODEL 1020TK891905CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE

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Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, 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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