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FDA 510(k)

AMBULATORY INFUSION PUMP DRUG RESERVOIR

K-Number: K870524 · 1987-05-06

ApplicantMed Fusion Systems, Inc.
Decision Date1987-05-06
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMBULATORY INFUSION PUMP DRUG RESERVOIR 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 1987-05-06 under 510(k) number K870524. 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 AMBULATORY INFUSION PUMP DRUG RESERVOIR?

AMBULATORY INFUSION PUMP DRUG RESERVOIR is a medical device that received FDA 510(k) clearance on 1987-05-06. The listed applicant is Med Fusion Systems, Inc.. The 510(k) number is K870524.

When did AMBULATORY INFUSION PUMP DRUG RESERVOIR receive FDA 510(k) clearance?

AMBULATORY INFUSION PUMP DRUG RESERVOIR received FDA 510(k) clearance on 1987-05-06, under 510(k) number K870524.

Who is the listed applicant for AMBULATORY INFUSION PUMP DRUG RESERVOIR?

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 AMBULATORY INFUSION PUMP DRUG RESERVOIR?

The FDA product code for AMBULATORY INFUSION PUMP DRUG RESERVOIR is FRN.

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Other records listing Med Fusion 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.

K873961INFUMED 300 AMBULATORY INFUSION PUMPK870907INTRODUCER, PERCUTANEOUSK864407REFILLABLE SYRINGEK863814BAG SPIKE EXTENSION SETK860616VOLUME CONTROL SET WITH EXTENSIONK860803IV FILTER EXTENSION SET

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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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