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FDA 510(k)

ULTRAFLO RATESAVER PLUS INFUSION PUMP

K-Number: K921050 · 1993-08-03

ApplicantClinical Systems, Inc.
Decision Date1993-08-03
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ULTRAFLO RATESAVER PLUS INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Systems, Inc.. It received FDA 510(k) clearance on 1993-08-03 under 510(k) number K921050. 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 ULTRAFLO RATESAVER PLUS INFUSION PUMP?

ULTRAFLO RATESAVER PLUS INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1993-08-03. The listed applicant is Clinical Systems, Inc.. The 510(k) number is K921050.

When did ULTRAFLO RATESAVER PLUS INFUSION PUMP receive FDA 510(k) clearance?

ULTRAFLO RATESAVER PLUS INFUSION PUMP received FDA 510(k) clearance on 1993-08-03, under 510(k) number K921050.

Who is the listed applicant for ULTRAFLO RATESAVER PLUS INFUSION PUMP?

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

What is the FDA product code for ULTRAFLO RATESAVER PLUS INFUSION PUMP?

The FDA product code for ULTRAFLO RATESAVER PLUS 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_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 Clinical 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.

K915061PROACT CLA-1500 SYSTEMK901458NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP

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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