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FDA 510(k)

AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K982076 · 1998-12-10

ApplicantAmira Medical, Inc.
Decision Date1998-12-10
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Amira Medical, Inc.. It received FDA 510(k) clearance on 1998-12-10 under 510(k) number K982076. 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 AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM?

AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-12-10. The listed applicant is Amira Medical, Inc.. The 510(k) number is K982076.

When did AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 1998-12-10, under 510(k) number K982076.

Who is the listed applicant for AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM?

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

What is the FDA product code for AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM is CGA.

Related Clinical Trials

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Other records listing Amira Medical, 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.

K010605ATLAST DATA MANAGEMENT SOFTWARE (DMS)K991075ATLAST GLUCOSE CONTROL SOLUTION

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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