STANDARD — FDA 510(k) K925752

Device Summary

STANDARD 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 K925752. 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 STANDARD?

STANDARD 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 K925752.

When did STANDARD receive FDA 510(k) clearance?

STANDARD received FDA 510(k) clearance on 1993-10-08, under 510(k) number K925752.

Who is the listed applicant for STANDARD?

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 STANDARD?

The FDA product code for STANDARD is ERA.

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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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Related Devices (Code: ERA)

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K123821AIO HD OTOSCOPEBlue Focus K121326LANTOS 3D EAR SCANNERLantos Technologies K110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, Inc.

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.