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FDA 510(k)

MICROFUSE DUAL RATE INFUSER

K-Number: K983321 · 1998-10-06

ApplicantBaxa Corp.
Decision Date1998-10-06
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MICROFUSE DUAL RATE INFUSER is the device name listed in this FDA 510(k) record. The listed applicant is Baxa Corp.. It received FDA 510(k) clearance on 1998-10-06 under 510(k) number K983321. 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 MICROFUSE DUAL RATE INFUSER?

MICROFUSE DUAL RATE INFUSER is a medical device that received FDA 510(k) clearance on 1998-10-06. The listed applicant is Baxa Corp.. The 510(k) number is K983321.

When did MICROFUSE DUAL RATE INFUSER receive FDA 510(k) clearance?

MICROFUSE DUAL RATE INFUSER received FDA 510(k) clearance on 1998-10-06, under 510(k) number K983321.

Who is the listed applicant for MICROFUSE DUAL RATE INFUSER?

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

What is the FDA product code for MICROFUSE DUAL RATE INFUSER?

The FDA product code for MICROFUSE DUAL RATE INFUSER is FRN.

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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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