FDA 510(k)

Hysteroscope System

Número K: K181545 · 2019-05-10

RequerenteShanghai AnQing Medical Instrument Co., Ltd.

Data da decisão2019-05-10

Código do produtoHIH

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hysteroscope System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2019-05-10 under 510(k) number K181545. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Hysteroscope System?

Hysteroscope System is a medical device that received FDA 510(k) clearance on 2019-05-10. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K181545.

When did Hysteroscope System receive FDA 510(k) clearance?

Hysteroscope System received FDA 510(k) clearance on 2019-05-10, under 510(k) number K181545.

Who is the listed applicant for Hysteroscope System?

The FDA 510(k) record lists Shanghai AnQing Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hysteroscope System?

The FDA product code for Hysteroscope System is HIH.

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Outros registros que listam Shanghai AnQing Medical Instrument Co., Ltd. como candidato(a)

K254251InnovexView (GC146-17, GC150-20, GC155-23)K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

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Fonte oficial

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