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FDA 510(k)

9000 INFUSION PUMP

K-Number: K944721 · 1995-08-11

ApplicantGraseby Medical , Ltd.
Decision Date1995-08-11
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

9000 INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Graseby Medical , Ltd.. It received FDA 510(k) clearance on 1995-08-11 under 510(k) number K944721. 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 9000 INFUSION PUMP?

9000 INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1995-08-11. The listed applicant is Graseby Medical , Ltd.. The 510(k) number is K944721.

When did 9000 INFUSION PUMP receive FDA 510(k) clearance?

9000 INFUSION PUMP received FDA 510(k) clearance on 1995-08-11, under 510(k) number K944721.

Who is the listed applicant for 9000 INFUSION PUMP?

The FDA 510(k) record lists Graseby Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 9000 INFUSION PUMP?

The FDA product code for 9000 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 Graseby Medical , Ltd. 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.

K9313183400 INFUSION PUMPK915270PATIENT CONTROLLED SYRINGE PUMP TYPE 3300K9121933000 INFUSION PUMPK9121923100 INFUSION 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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