Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)

K-Number: K992672 · 1999-08-24

ApplicantBelmont Instrument Corp.
Decision Date1999-08-24
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) is the device name listed in this FDA 510(k) record. The listed applicant is Belmont Instrument Corp.. It received FDA 510(k) clearance on 1999-08-24 under 510(k) number K992672. 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 BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)?

BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) is a medical device that received FDA 510(k) clearance on 1999-08-24. The listed applicant is Belmont Instrument Corp.. The 510(k) number is K992672.

When did BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) receive FDA 510(k) clearance?

BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) received FDA 510(k) clearance on 1999-08-24, under 510(k) number K992672.

Who is the listed applicant for BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)?

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

What is the FDA product code for BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)?

The FDA product code for BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Belmont Instrument Corp. 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.

K131519BELMONT HYPERTHERMIA PUMPK112639THE BELMONT BUDDY LITE FLUID WARMERK091855THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000K090508THE BELMONT BUDDY LITE FLUID WARMERK090089BELMONT HYPERTHERMIA PUMPK070654HYPERTHERMIA PUMP

View all 20 devices →

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.

↑