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FDA 510(k)

DALTEX IV INFUSION PUMP

K-Number: K863470 · 1987-01-05

ApplicantDaltex Medical Sciences, Inc.
Decision Date1987-01-05
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DALTEX IV INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Daltex Medical Sciences, Inc.. It received FDA 510(k) clearance on 1987-01-05 under 510(k) number K863470. 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 DALTEX IV INFUSION PUMP?

DALTEX IV INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1987-01-05. The listed applicant is Daltex Medical Sciences, Inc.. The 510(k) number is K863470.

When did DALTEX IV INFUSION PUMP receive FDA 510(k) clearance?

DALTEX IV INFUSION PUMP received FDA 510(k) clearance on 1987-01-05, under 510(k) number K863470.

Who is the listed applicant for DALTEX IV INFUSION PUMP?

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

What is the FDA product code for DALTEX IV INFUSION PUMP?

The FDA product code for DALTEX IV INFUSION PUMP is FRN.

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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.

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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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