FDA 510(k)

ReliOn Premier BLU Blood Glucose Monitoring System

K-Nummer: K230625 · 2023-08-10

Entscheidungsdatum2023-08-10

ProduktcodeNBW

BeratungsausschussCH

EntscheidungSubstantially Equivalent

Produktübersicht

ReliOn Premier BLU Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is I-Sens, Inc.. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K230625. 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.

Häufig gestellte Fragen

What is the ReliOn Premier BLU Blood Glucose Monitoring System?

ReliOn Premier BLU Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is I-Sens, Inc.. The 510(k) number is K230625.

When did ReliOn Premier BLU Blood Glucose Monitoring System receive FDA 510(k) clearance?

ReliOn Premier BLU Blood Glucose Monitoring System received FDA 510(k) clearance on 2023-08-10, under 510(k) number K230625.

Who is the listed applicant for ReliOn Premier BLU Blood Glucose Monitoring System?

The FDA 510(k) record lists I-Sens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ReliOn Premier BLU Blood Glucose Monitoring System?

The FDA product code for ReliOn Premier BLU Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Weitere Einträge mit I-Sens, Inc. als Antragsteller

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