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FDA 510(k)

REPRO-MED SYSTEMS INFUSION DEVICE

K-Number: K844401 · 1985-03-12

ApplicantRepro-Med Systems, Inc.
Decision Date1985-03-12
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

REPRO-MED SYSTEMS INFUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Repro-Med Systems, Inc.. It received FDA 510(k) clearance on 1985-03-12 under 510(k) number K844401. 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 REPRO-MED SYSTEMS INFUSION DEVICE?

REPRO-MED SYSTEMS INFUSION DEVICE is a medical device that received FDA 510(k) clearance on 1985-03-12. The listed applicant is Repro-Med Systems, Inc.. The 510(k) number is K844401.

When did REPRO-MED SYSTEMS INFUSION DEVICE receive FDA 510(k) clearance?

REPRO-MED SYSTEMS INFUSION DEVICE received FDA 510(k) clearance on 1985-03-12, under 510(k) number K844401.

Who is the listed applicant for REPRO-MED SYSTEMS INFUSION DEVICE?

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

What is the FDA product code for REPRO-MED SYSTEMS INFUSION DEVICE?

The FDA product code for REPRO-MED SYSTEMS INFUSION DEVICE is FRN.

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Other records listing Repro-Med 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.

K102512RMS SUBCUTANEOUS NEEDLE SETK981506RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)K933652FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBINGK894299REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEMK892529REPRO-MED NEONATE ASPIRATION SYSTEM

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

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

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