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FDA 510(k)

HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]

K-Number: K993128 · 1999-11-23

ApplicantHealth Hero Network, Inc.
Decision Date1999-11-23
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] is the device name listed in this FDA 510(k) record. The listed applicant is Health Hero Network, Inc.. It received FDA 510(k) clearance on 1999-11-23 under 510(k) number K993128. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]?

HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] is a medical device that received FDA 510(k) clearance on 1999-11-23. The listed applicant is Health Hero Network, Inc.. The 510(k) number is K993128.

When did HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] receive FDA 510(k) clearance?

HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] received FDA 510(k) clearance on 1999-11-23, under 510(k) number K993128.

Who is the listed applicant for HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]?

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

What is the FDA product code for HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]?

The FDA product code for HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] is CGA.

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Other records listing Health Hero Network, Inc. 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.

K080091MODIFICATION TO:HEALTH BUDDY APPLIANCEK070543MODIFICATION TO HEALTH BUDDY APPLIANCEK063612MODIFICATION TO HEALTH BUDDY APPLIANCEK060843MODIFICATION TO HEALTH BUDDY APPLIANCEK050567HEALTH BUDDY APPLIANCEK042273MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY

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Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.

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.

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