FDA 510(k)

MEDRAD VARIBLE INFUSION INJECTOR

K-Number: K905819 · 1991-09-16

Decision Date1991-09-16

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDRAD VARIBLE INFUSION INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 1991-09-16 under 510(k) number K905819. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDRAD VARIBLE INFUSION INJECTOR?

MEDRAD VARIBLE INFUSION INJECTOR is a medical device that received FDA 510(k) clearance on 1991-09-16. The listed applicant is Medrad, Inc.. The 510(k) number is K905819.

When did MEDRAD VARIBLE INFUSION INJECTOR receive FDA 510(k) clearance?

MEDRAD VARIBLE INFUSION INJECTOR received FDA 510(k) clearance on 1991-09-16, under 510(k) number K905819.

Who is the listed applicant for MEDRAD VARIBLE INFUSION INJECTOR?

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

What is the FDA product code for MEDRAD VARIBLE INFUSION INJECTOR?

The FDA product code for MEDRAD VARIBLE INFUSION INJECTOR is DXT.

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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.