FDA 510(k)

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System

N.º K: K201037 · 2022-06-16

SolicitanteTaidoc Technology Corporation

Fecha de decisión2022-06-16

Código de productoNBW

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K201037. 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.

Preguntas frecuentes

What is the FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System?

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K201037.

When did FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System receive FDA 510(k) clearance?

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System received FDA 510(k) clearance on 2022-06-16, under 510(k) number K201037.

Who is the listed applicant for FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System?

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

What is the FDA product code for FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System?

The FDA product code for FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System is NBW. This falls under the OB/GYN category.

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 Taidoc Technology Corporation como solicitante

K221349XPER Technology PREMIUM Pro Blood Glucose Monitoring System K200946Termómetro de frente Clever / Termómetro de frente médico Clever (Modelo TD-1241)K190579TD-4183 Blood Glucose Monitoring System K182934FORA P100 Blood Pressure Monitoring System K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator K181675FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System

Ver todos los 17 dispositivos →

Dispositivos relacionados (Código: NBW)

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K262116TRUE 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 Corporation K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

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.