FDA 510(k)

UNI I

K-Number: K925759 · 1993-07-26

Decision Date1993-07-26

Product CodeERA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

UNI I 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 1993-07-26 under 510(k) number K925759. 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 I?

UNI I is a medical device that received FDA 510(k) clearance on 1993-07-26. The listed applicant is Rudolf Riester GmbH & Co. KG. The 510(k) number is K925759.

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

UNI I received FDA 510(k) clearance on 1993-07-26, under 510(k) number K925759.

Who is the listed applicant for UNI I?

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 I?

The FDA product code for UNI I 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.