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FDA 510(k)

PRODIGY DIABETES MANAGEMENT SOFTWARE

K-Number: K103115 · 2011-10-12

ApplicantProdigy Diabetes Care, LLC
Decision Date2011-10-12
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRODIGY DIABETES MANAGEMENT SOFTWARE 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 2011-10-12 under 510(k) number K103115. 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 DIABETES MANAGEMENT SOFTWARE?

PRODIGY DIABETES MANAGEMENT SOFTWARE is a medical device that received FDA 510(k) clearance on 2011-10-12. The listed applicant is Prodigy Diabetes Care, LLC. The 510(k) number is K103115.

When did PRODIGY DIABETES MANAGEMENT SOFTWARE receive FDA 510(k) clearance?

PRODIGY DIABETES MANAGEMENT SOFTWARE received FDA 510(k) clearance on 2011-10-12, under 510(k) number K103115.

Who is the listed applicant for PRODIGY DIABETES MANAGEMENT SOFTWARE?

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 DIABETES MANAGEMENT SOFTWARE?

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

Related Clinical Trials

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.

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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.

K122340PRODIGY CHOICEK122338PREFERRED BLOOD GLUCOSE MONITORING SYSTEM

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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