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FDA 510(k)

ATLAST GLUCOSE CONTROL SOLUTION

K-Number: K991075 · 1999-05-10

ApplicantAmira Medical, Inc.
Decision Date1999-05-10
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATLAST GLUCOSE CONTROL SOLUTION 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 1999-05-10 under 510(k) number K991075. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATLAST GLUCOSE CONTROL SOLUTION?

ATLAST GLUCOSE CONTROL SOLUTION is a medical device that received FDA 510(k) clearance on 1999-05-10. The listed applicant is Amira Medical, Inc.. The 510(k) number is K991075.

When did ATLAST GLUCOSE CONTROL SOLUTION receive FDA 510(k) clearance?

ATLAST GLUCOSE CONTROL SOLUTION received FDA 510(k) clearance on 1999-05-10, under 510(k) number K991075.

Who is the listed applicant for ATLAST GLUCOSE CONTROL SOLUTION?

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 GLUCOSE CONTROL SOLUTION?

The FDA product code for ATLAST GLUCOSE CONTROL SOLUTION is JJX.

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)K982076AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM

Related Devices (Code: JJX)

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Official Source

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

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