FDA 510(k)

STERRAD 100NX Sterilizer with ALLClearTM Technology

Número K: K160903 · 2016-09-26

RequerenteAdvanced Sterilization Products

Data da decisão2016-09-26

Código do produtoMLR

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

STERRAD 100NX Sterilizer with ALLClearTM Technology is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products. It received FDA 510(k) clearance on 2016-09-26 under 510(k) number K160903. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the STERRAD 100NX Sterilizer with ALLClearTM Technology?

STERRAD 100NX Sterilizer with ALLClearTM Technology is a medical device that received FDA 510(k) clearance on 2016-09-26. The listed applicant is Advanced Sterilization Products. The 510(k) number is K160903.

When did STERRAD 100NX Sterilizer with ALLClearTM Technology receive FDA 510(k) clearance?

STERRAD 100NX Sterilizer with ALLClearTM Technology received FDA 510(k) clearance on 2016-09-26, under 510(k) number K160903.

Who is the listed applicant for STERRAD 100NX Sterilizer with ALLClearTM Technology?

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

What is the FDA product code for STERRAD 100NX Sterilizer with ALLClearTM Technology?

The FDA product code for STERRAD 100NX Sterilizer with ALLClearTM Technology is MLR.

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Outros registros que listam Advanced Sterilization Products como candidato(a)

K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator K162007STERRAD NX Sterilizer K160818STERRAD® NX Sterilizer with ALLClear™ Technology K151725STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

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

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