FDA 510(k)

TYSONBIO LINK HEALTH MANAGEMENT SYSTEM

K-Number: K081726 · 2008-08-26

Decision Date2008-08-26

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TYSONBIO LINK HEALTH MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tyson Bioresearch, Inc.. It received FDA 510(k) clearance on 2008-08-26 under 510(k) number K081726. 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 TYSONBIO LINK HEALTH MANAGEMENT SYSTEM?

TYSONBIO LINK HEALTH MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-08-26. The listed applicant is Tyson Bioresearch, Inc.. The 510(k) number is K081726.

When did TYSONBIO LINK HEALTH MANAGEMENT SYSTEM receive FDA 510(k) clearance?

TYSONBIO LINK HEALTH MANAGEMENT SYSTEM received FDA 510(k) clearance on 2008-08-26, under 510(k) number K081726.

Who is the listed applicant for TYSONBIO LINK HEALTH MANAGEMENT SYSTEM?

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

What is the FDA product code for TYSONBIO LINK HEALTH MANAGEMENT SYSTEM?

The FDA product code for TYSONBIO LINK HEALTH MANAGEMENT SYSTEM is NBW. This falls under the OB/GYN category.

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Other records listing Tyson Bioresearch, Inc. as applicant

K182046Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System K182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System K123087TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM K112916TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM K101543TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200

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Related Devices (Code: NBW)

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Official Source

View on FDA Database →

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