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FDA 510(k)

AVI MODEL 600 SYRINGE PUMP, MODIFICATION

K-Number: K904979 · 1991-01-15

Applicant3M Avi, Inc.
Decision Date1991-01-15
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AVI MODEL 600 SYRINGE PUMP, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is 3M Avi, Inc.. It received FDA 510(k) clearance on 1991-01-15 under 510(k) number K904979. 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 AVI MODEL 600 SYRINGE PUMP, MODIFICATION?

AVI MODEL 600 SYRINGE PUMP, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-01-15. The listed applicant is 3M Avi, Inc.. The 510(k) number is K904979.

When did AVI MODEL 600 SYRINGE PUMP, MODIFICATION receive FDA 510(k) clearance?

AVI MODEL 600 SYRINGE PUMP, MODIFICATION received FDA 510(k) clearance on 1991-01-15, under 510(k) number K904979.

Who is the listed applicant for AVI MODEL 600 SYRINGE PUMP, MODIFICATION?

The FDA 510(k) record lists 3M Avi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVI MODEL 600 SYRINGE PUMP, MODIFICATION?

The FDA product code for AVI MODEL 600 SYRINGE PUMP, MODIFICATION is FRN.

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Other records listing 3M Avi, 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.

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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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