FDA 510(k)

KDF-2.3

K-Number: K894264 · 1989-08-15

Decision Date1989-08-15

Product CodeHDR

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

KDF-2.3 is the device name listed in this FDA 510(k) record. The listed applicant is Unimar, Inc.. It received FDA 510(k) clearance on 1989-08-15 under 510(k) number K894264. The device is classified under product code HDR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KDF-2.3?

KDF-2.3 is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Unimar, Inc.. The 510(k) number is K894264.

When did KDF-2.3 receive FDA 510(k) clearance?

KDF-2.3 received FDA 510(k) clearance on 1989-08-15, under 510(k) number K894264.

Who is the listed applicant for KDF-2.3?

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

What is the FDA product code for KDF-2.3?

The FDA product code for KDF-2.3 is HDR.

Other records listing Unimar, Inc. as applicant

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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.