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FDA 510(k)

ATLAST DATA MANAGEMENT SOFTWARE (DMS)

K-Number: K010605 · 2001-05-07

ApplicantAmira Medical, Inc.
Decision Date2001-05-07
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATLAST DATA MANAGEMENT SOFTWARE (DMS) 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 2001-05-07 under 510(k) number K010605. 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 ATLAST DATA MANAGEMENT SOFTWARE (DMS)?

ATLAST DATA MANAGEMENT SOFTWARE (DMS) is a medical device that received FDA 510(k) clearance on 2001-05-07. The listed applicant is Amira Medical, Inc.. The 510(k) number is K010605.

When did ATLAST DATA MANAGEMENT SOFTWARE (DMS) receive FDA 510(k) clearance?

ATLAST DATA MANAGEMENT SOFTWARE (DMS) received FDA 510(k) clearance on 2001-05-07, under 510(k) number K010605.

Who is the listed applicant for ATLAST DATA MANAGEMENT SOFTWARE (DMS)?

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 ATLAST DATA MANAGEMENT SOFTWARE (DMS)?

The FDA product code for ATLAST DATA MANAGEMENT SOFTWARE (DMS) is CGA.

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 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.

K991075ATLAST GLUCOSE CONTROL SOLUTIONK982076AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM

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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