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FDA 510(k)

SteroScope® Sterilization Technology System

N.º K: K233762 · 2024-06-27

SolicitanteIdeate Medical, Inc.
Fecha de decisión2024-06-27
Código de productoMLR
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

SteroScope® Sterilization Technology System is the device name listed in this FDA 510(k) record. The listed applicant is Ideate Medical, Inc.. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K233762. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SteroScope® Sterilization Technology System?

SteroScope® Sterilization Technology System is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Ideate Medical, Inc.. The 510(k) number is K233762.

When did SteroScope® Sterilization Technology System receive FDA 510(k) clearance?

SteroScope® Sterilization Technology System received FDA 510(k) clearance on 2024-06-27, under 510(k) number K233762.

Who is the listed applicant for SteroScope® Sterilization Technology System?

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

What is the FDA product code for SteroScope® Sterilization Technology System?

The FDA product code for SteroScope® Sterilization Technology System is MLR.

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Dispositivos relacionados (Código: MLR)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc.K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc.K231893LOWTEM Crystal 120Lowtem Co., Ltd.K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)Advanced Sterilization ProductsK233065V-PRO maX 2 Low Temperature Sterilization SystemSterisK223476V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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