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FDA 510(k)

SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System

Número K: K160282 · 2017-10-17

RequerenteSd Biosensor
Data da decisão2017-10-17
Código do produtoNBW
Comité consultivoCH
DecisãoSubstantially Equivalent

Resumo do dispositivo

SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System is the device name listed in this FDA 510(k) record. The listed applicant is Sd Biosensor. It received FDA 510(k) clearance on 2017-10-17 under 510(k) number K160282. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System?

SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System is a medical device that received FDA 510(k) clearance on 2017-10-17. The listed applicant is Sd Biosensor. The 510(k) number is K160282.

When did SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System receive FDA 510(k) clearance?

SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System received FDA 510(k) clearance on 2017-10-17, under 510(k) number K160282.

Who is the listed applicant for SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System?

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

What is the FDA product code for SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System?

The FDA product code for SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System is NBW. This falls under the OB/GYN category.

Ensaios clínicos relacionados

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Outros registros que listam Sd Biosensor como candidato(a)

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Dispositivos Relacionados (Código: NBW)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes CareK262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime CorporationK240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

Fonte oficial

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