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FDA 510(k)

PERFECT, ENT SET, PRAKTIKANT, DE LUXE

K-Number: K950913 · 1995-05-12

ApplicantRudolf Riester GmbH & Co. KG
Decision Date1995-05-12
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PERFECT, ENT SET, PRAKTIKANT, DE LUXE 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 1995-05-12 under 510(k) number K950913. 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 PERFECT, ENT SET, PRAKTIKANT, DE LUXE?

PERFECT, ENT SET, PRAKTIKANT, DE LUXE is a medical device that received FDA 510(k) clearance on 1995-05-12. The listed applicant is Rudolf Riester GmbH & Co. KG. The 510(k) number is K950913.

When did PERFECT, ENT SET, PRAKTIKANT, DE LUXE receive FDA 510(k) clearance?

PERFECT, ENT SET, PRAKTIKANT, DE LUXE received FDA 510(k) clearance on 1995-05-12, under 510(k) number K950913.

Who is the listed applicant for PERFECT, ENT SET, PRAKTIKANT, DE LUXE?

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 PERFECT, ENT SET, PRAKTIKANT, DE LUXE?

The FDA product code for PERFECT, ENT SET, PRAKTIKANT, DE LUXE 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 MANOMETERSK002955EMPIRE N BLOOD PRESSURE MANOMETERSK972377RI-MEGAK972378SANAPHON NK972379PRECISA NK972301BIG BEN SQUARE, BIG BEN ROUND

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Related Devices (Code: ERA)

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.

K123821AIO HD OTOSCOPEBlue FocusK121326LANTOS 3D EAR SCANNERLantos TechnologiesK110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, Inc.

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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