FDA 510(k)

UNI III

K-Number: K925753 · 1993-10-08

Decision Date1993-10-08

Product CodeERA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

UNI III is the device name listed in this FDA 510(k) record. The listed applicant is Rudolf Riester GmbH & Co. KG. It received FDA 510(k) clearance on 1993-10-08 under 510(k) number K925753. The device is classified under product code ERA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI III?

UNI III is a medical device that received FDA 510(k) clearance on 1993-10-08. The listed applicant is Rudolf Riester GmbH & Co. KG. The 510(k) number is K925753.

When did UNI III receive FDA 510(k) clearance?

UNI III received FDA 510(k) clearance on 1993-10-08, under 510(k) number K925753.

Who is the listed applicant for UNI III?

The FDA 510(k) record lists Rudolf Riester GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNI III?

The FDA product code for UNI III is ERA.

Other records listing Rudolf Riester GmbH & Co. KG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K002954RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS K002955EMPIRE N BLOOD PRESSURE MANOMETERS K972377RI-MEGA K972378SANAPHON N K972379PRECISA N K972301BIG BEN SQUARE, BIG BEN ROUND

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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.