FDA 510(k)

INFUMED 300 AMBULATORY INFUSION PUMP

K-Number: K873961 · 1987-12-29

Decision Date1987-12-29

Product CodeFRN

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

INFUMED 300 AMBULATORY INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Med Fusion Systems, Inc.. It received FDA 510(k) clearance on 1987-12-29 under 510(k) number K873961. 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 INFUMED 300 AMBULATORY INFUSION PUMP?

INFUMED 300 AMBULATORY INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1987-12-29. The listed applicant is Med Fusion Systems, Inc.. The 510(k) number is K873961.

When did INFUMED 300 AMBULATORY INFUSION PUMP receive FDA 510(k) clearance?

INFUMED 300 AMBULATORY INFUSION PUMP received FDA 510(k) clearance on 1987-12-29, under 510(k) number K873961.

Who is the listed applicant for INFUMED 300 AMBULATORY INFUSION PUMP?

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

What is the FDA product code for INFUMED 300 AMBULATORY INFUSION PUMP?

The FDA product code for INFUMED 300 AMBULATORY INFUSION PUMP is FRN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Med Fusion Systems, Inc. as applicant

K870524AMBULATORY INFUSION PUMP DRUG RESERVOIR K870907INTRODUCER, PERCUTANEOUS K864407REFILLABLE SYRINGE K863814BAG SPIKE EXTENSION SET K860616VOLUME CONTROL SET WITH EXTENSION K860803IV FILTER EXTENSION SET

View all 22 devices →

Related Devices (Code: FRN)

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp K252015FreedomEdge 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 Corporation K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation K243855BD 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.