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FDA 510(k)

UNIVUE I

K-Number: K770954 · 1977-07-01

ApplicantUnion Carbide Corp.
Decision Date1977-07-01
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNIVUE I is the device name listed in this FDA 510(k) record. The listed applicant is Union Carbide Corp.. It received FDA 510(k) clearance on 1977-07-01 under 510(k) number K770954. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVUE I?

UNIVUE I is a medical device that received FDA 510(k) clearance on 1977-07-01. The listed applicant is Union Carbide Corp.. The 510(k) number is K770954.

When did UNIVUE I receive FDA 510(k) clearance?

UNIVUE I received FDA 510(k) clearance on 1977-07-01, under 510(k) number K770954.

Who is the listed applicant for UNIVUE I?

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

What is the FDA product code for UNIVUE I?

The FDA product code for UNIVUE I is IYX.

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Other records listing Union Carbide Corp. as applicant

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Related Devices (Code: IYX)

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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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