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FDA 510(k)

TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF

K-Number: K893519 · 1989-08-15

ApplicantStatlabs, Inc.
Decision Date1989-08-15
Product CodeKZB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF is the device name listed in this FDA 510(k) record. The listed applicant is Statlabs, Inc.. It received FDA 510(k) clearance on 1989-08-15 under 510(k) number K893519. The device is classified under product code KZB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF?

TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Statlabs, Inc.. The 510(k) number is K893519.

When did TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF receive FDA 510(k) clearance?

TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF received FDA 510(k) clearance on 1989-08-15, under 510(k) number K893519.

Who is the listed applicant for TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF?

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

What is the FDA product code for TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF?

The FDA product code for TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF is KZB.

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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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