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FDA 510(k)

SMARTDOSE IV PREFILLED INFUSION CONTAINER

K-Number: K944351 · 1995-11-15

ApplicantRiver Medical, Inc.
Decision Date1995-11-15
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

SMARTDOSE IV PREFILLED INFUSION CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is River Medical, Inc.. It received FDA 510(k) clearance on 1995-11-15 under 510(k) number K944351. 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 SMARTDOSE IV PREFILLED INFUSION CONTAINER?

SMARTDOSE IV PREFILLED INFUSION CONTAINER is a medical device that received FDA 510(k) clearance on 1995-11-15. The listed applicant is River Medical, Inc.. The 510(k) number is K944351.

When did SMARTDOSE IV PREFILLED INFUSION CONTAINER receive FDA 510(k) clearance?

SMARTDOSE IV PREFILLED INFUSION CONTAINER received FDA 510(k) clearance on 1995-11-15, under 510(k) number K944351.

Who is the listed applicant for SMARTDOSE IV PREFILLED INFUSION CONTAINER?

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

What is the FDA product code for SMARTDOSE IV PREFILLED INFUSION CONTAINER?

The FDA product code for SMARTDOSE IV PREFILLED INFUSION CONTAINER is FRN.

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Other records listing River Medical, 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.

K023174DISPOSABLE TEMPORARY PACING WIREK944352SMARTDOSE III INFUSION CONTAINERK945298SMARTFLOW I ADMINISTRATION SETK943692SMART DOSE(TM)K932895RIVER PUMPK933335RIVER VIAL ADAPTER

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Related Devices (Code: FRN)

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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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