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FDA 510(k)

MODEL 1200 ABMULATORY INFUSION PUMP

K-Number: K961263 · 1996-08-23

ApplicantPatient Solutions, Inc.
Decision Date1996-08-23
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

MODEL 1200 ABMULATORY INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Patient Solutions, Inc.. It received FDA 510(k) clearance on 1996-08-23 under 510(k) number K961263. 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 MODEL 1200 ABMULATORY INFUSION PUMP?

MODEL 1200 ABMULATORY INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1996-08-23. The listed applicant is Patient Solutions, Inc.. The 510(k) number is K961263.

When did MODEL 1200 ABMULATORY INFUSION PUMP receive FDA 510(k) clearance?

MODEL 1200 ABMULATORY INFUSION PUMP received FDA 510(k) clearance on 1996-08-23, under 510(k) number K961263.

Who is the listed applicant for MODEL 1200 ABMULATORY INFUSION PUMP?

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

What is the FDA product code for MODEL 1200 ABMULATORY INFUSION PUMP?

The FDA product code for MODEL 1200 ABMULATORY 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 Patient Solutions, 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.

K964384MODEL D-290P ADMINISTRATION SETK954841MODEL D-285N ADMINISTRATION SETK953270MODEL 1100 MEDMATE INFUSION PUMPK894028AMBULATORY INFUSION SYSTEM AND ACCESSORIES

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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