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FDA 510(k)

MDT2 BLE Self-Monitoring Blood Glucose System

Numéro K : K190189 · 2019-11-01

DemandeurEps Bio Technology Corp.
Date de décision2019-11-01
Code produitNBW
Comité consultatifCH
DécisionSubstantially Equivalent

Résumé du dispositif

MDT2 BLE Self-Monitoring Blood Glucose System is the device name listed in this FDA 510(k) record. The listed applicant is Eps Bio Technology Corp.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K190189. 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.

Questions fréquentes

What is the MDT2 BLE Self-Monitoring Blood Glucose System?

MDT2 BLE Self-Monitoring Blood Glucose System is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Eps Bio Technology Corp.. The 510(k) number is K190189.

When did MDT2 BLE Self-Monitoring Blood Glucose System receive FDA 510(k) clearance?

MDT2 BLE Self-Monitoring Blood Glucose System received FDA 510(k) clearance on 2019-11-01, under 510(k) number K190189.

Who is the listed applicant for MDT2 BLE Self-Monitoring Blood Glucose System?

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

What is the FDA product code for MDT2 BLE Self-Monitoring Blood Glucose System?

The FDA product code for MDT2 BLE Self-Monitoring Blood Glucose System is NBW. This falls under the OB/GYN category.

Essais cliniques associés

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Autres dossiers indiquant Eps Bio Technology Corp. en tant que demandeur

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : NBW)

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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.

Source officielle

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