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FDA 510(k)

STRATOFUSE PCA II INFUSER

K-Number: K941151 · 1994-07-07

ApplicantInfusion Technology Intl.
Decision Date1994-07-07
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STRATOFUSE PCA II INFUSER is the device name listed in this FDA 510(k) record. The listed applicant is Infusion Technology Intl.. It received FDA 510(k) clearance on 1994-07-07 under 510(k) number K941151. 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 STRATOFUSE PCA II INFUSER?

STRATOFUSE PCA II INFUSER is a medical device that received FDA 510(k) clearance on 1994-07-07. The listed applicant is Infusion Technology Intl.. The 510(k) number is K941151.

When did STRATOFUSE PCA II INFUSER receive FDA 510(k) clearance?

STRATOFUSE PCA II INFUSER received FDA 510(k) clearance on 1994-07-07, under 510(k) number K941151.

Who is the listed applicant for STRATOFUSE PCA II INFUSER?

The FDA 510(k) record lists Infusion Technology Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRATOFUSE PCA II INFUSER?

The FDA product code for STRATOFUSE PCA II INFUSER 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.

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Other records listing Infusion Technology Intl. 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.

K943591VECTOR(TM) AMBULATORY DRUG DELIVERY SYSTEMK935461VECTOR AMBULATORY DRUG DELIVERY SYSTEM

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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