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FDA 510(k)

PRODIGY CHOICE

K-Number: K122340 · 2013-11-26

ApplicantProdigy Diabetes Care, LLC
Decision Date2013-11-26
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRODIGY CHOICE is the device name listed in this FDA 510(k) record. The listed applicant is Prodigy Diabetes Care, LLC. It received FDA 510(k) clearance on 2013-11-26 under 510(k) number K122340. 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.

Frequently Asked Questions

What is the PRODIGY CHOICE?

PRODIGY CHOICE is a medical device that received FDA 510(k) clearance on 2013-11-26. The listed applicant is Prodigy Diabetes Care, LLC. The 510(k) number is K122340.

When did PRODIGY CHOICE receive FDA 510(k) clearance?

PRODIGY CHOICE received FDA 510(k) clearance on 2013-11-26, under 510(k) number K122340.

Who is the listed applicant for PRODIGY CHOICE?

The FDA 510(k) record lists Prodigy Diabetes Care, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRODIGY CHOICE?

The FDA product code for PRODIGY CHOICE is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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Other records listing Prodigy Diabetes Care, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122338PREFERRED BLOOD GLUCOSE MONITORING SYSTEMK103115PRODIGY DIABETES MANAGEMENT SOFTWARE

Related Devices (Code: NBW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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