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FDA 510(k)

UNIVOX-IC

K-Number: K895356 · 1990-03-06

ApplicantBaxter Healthcare Corp
Decision Date1990-03-06
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNIVOX-IC is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1990-03-06 under 510(k) number K895356. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVOX-IC?

UNIVOX-IC is a medical device that received FDA 510(k) clearance on 1990-03-06. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K895356.

When did UNIVOX-IC receive FDA 510(k) clearance?

UNIVOX-IC received FDA 510(k) clearance on 1990-03-06, under 510(k) number K895356.

Who is the listed applicant for UNIVOX-IC?

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

What is the FDA product code for UNIVOX-IC?

The FDA product code for UNIVOX-IC is DTN.

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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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