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FDA 510(k)

FORA V10 BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K121706 · 2013-01-14

ApplicantForacare, Inc.
Decision Date2013-01-14
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FORA V10 BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Foracare, Inc.. It received FDA 510(k) clearance on 2013-01-14 under 510(k) number K121706. 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 FORA V10 BLOOD GLUCOSE MONITORING SYSTEM?

FORA V10 BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-01-14. The listed applicant is Foracare, Inc.. The 510(k) number is K121706.

When did FORA V10 BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

FORA V10 BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2013-01-14, under 510(k) number K121706.

Who is the listed applicant for FORA V10 BLOOD GLUCOSE MONITORING SYSTEM?

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

What is the FDA product code for FORA V10 BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for FORA V10 BLOOD GLUCOSE MONITORING SYSTEM is CGA.

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Other records listing Foracare, 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.

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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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