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FDA 510(k)

FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING

K-Number: K933652 · 1994-05-18

ApplicantRepro-Med Systems, Inc.
Decision Date1994-05-18
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING 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 1994-05-18 under 510(k) number K933652. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING?

FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING is a medical device that received FDA 510(k) clearance on 1994-05-18. The listed applicant is Repro-Med Systems, Inc.. The 510(k) number is K933652.

When did FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING receive FDA 510(k) clearance?

FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING received FDA 510(k) clearance on 1994-05-18, under 510(k) number K933652.

Who is the listed applicant for FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING?

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 FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING?

The FDA product code for FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING is FRN.

Related Clinical Trials

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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)K894299REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEMK892529REPRO-MED NEONATE ASPIRATION SYSTEMK844401REPRO-MED SYSTEMS INFUSION DEVICE

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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