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FDA 510(k)

VARIABLE PRESSURE SYRINGE PUMP

K-Number: K974332 · 1998-12-29

ApplicantAlaris Medical Systems, Inc.
Decision Date1998-12-29
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VARIABLE PRESSURE SYRINGE PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Alaris Medical Systems, Inc.. It received FDA 510(k) clearance on 1998-12-29 under 510(k) number K974332. 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 VARIABLE PRESSURE SYRINGE PUMP?

VARIABLE PRESSURE SYRINGE PUMP is a medical device that received FDA 510(k) clearance on 1998-12-29. The listed applicant is Alaris Medical Systems, Inc.. The 510(k) number is K974332.

When did VARIABLE PRESSURE SYRINGE PUMP receive FDA 510(k) clearance?

VARIABLE PRESSURE SYRINGE PUMP received FDA 510(k) clearance on 1998-12-29, under 510(k) number K974332.

Who is the listed applicant for VARIABLE PRESSURE SYRINGE PUMP?

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

What is the FDA product code for VARIABLE PRESSURE SYRINGE PUMP?

The FDA product code for VARIABLE PRESSURE SYRINGE PUMP is FRN.

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Other records listing Alaris Medical Systems, Inc. as applicant

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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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