FDA 510(k)

EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F

Número K: K183525 · 2019-09-06

Data da decisão2019-09-06

Código do produtoPSV

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K183525. The device is classified under product code PSV. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F?

EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K183525.

When did EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F receive FDA 510(k) clearance?

EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F received FDA 510(k) clearance on 2019-09-06, under 510(k) number K183525.

Who is the listed applicant for EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F?

The FDA product code for EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F is PSV.

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Outros registros que listam Olympus Medical Systems Corp. como candidato(a)

K2620794K Camera Head OLYMPUS CH-S700-08-LB K254056THUNDERBEAT 5 mm, 45 cm, Tipo de Puxador Ativado na Frente S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Tipo de Puxador Ativado na Frente S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Tipo de Puxador Ativado na Frente S (TB-0520FCS)K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)

Ver todos os 80 dispositivos →

Dispositivos Relacionados (Código: PSV)

K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation

Fonte oficial

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