FDA 510(k)

V-PRO maX 2 Low Temperature Sterilization System

N.º K: K223476 · 2023-08-07

Fecha de decisión2023-08-07

Código de productoMLR

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

V-PRO maX 2 Low Temperature Sterilization System is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2023-08-07 under 510(k) number K223476. 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 V-PRO maX 2 Low Temperature Sterilization System?

V-PRO maX 2 Low Temperature Sterilization System is a medical device that received FDA 510(k) clearance on 2023-08-07. The listed applicant is STERIS Corporation. The 510(k) number is K223476.

When did V-PRO maX 2 Low Temperature Sterilization System receive FDA 510(k) clearance?

V-PRO maX 2 Low Temperature Sterilization System received FDA 510(k) clearance on 2023-08-07, under 510(k) number K223476.

Who is the listed applicant for V-PRO maX 2 Low Temperature Sterilization System?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V-PRO maX 2 Low Temperature Sterilization System?

The FDA product code for V-PRO maX 2 Low Temperature Sterilization System is MLR.

Ensayos clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a STERIS Corporation como solicitante

K261055AMSCO 700 Steam Sterilizer K260766Celerity 5 HP Biological Indicator (LCB052)K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 K252680Celerity™ 20 HP Biological Indicator K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 K243876VERIFY STEAM Integrating Indicator

Ver todos los 120 dispositivos →

Dispositivos relacionados (Código: MLR)

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 Products K233762SteroScope® Sterilization Technology SystemIdeate Medical, Inc.K233065V-PRO maX 2 Low Temperature Sterilization SystemSteris

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.