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FDA 510(k)

ATLAS MULTI-PURPOSE DSA SYSTEM

K-Number: K010391 · 2001-03-12

Decision Date2001-03-12
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ATLAS MULTI-PURPOSE DSA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cares Built, Inc.. It received FDA 510(k) clearance on 2001-03-12 under 510(k) number K010391. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATLAS MULTI-PURPOSE DSA SYSTEM?

ATLAS MULTI-PURPOSE DSA SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-12. The listed applicant is Cares Built, Inc.. The 510(k) number is K010391.

When did ATLAS MULTI-PURPOSE DSA SYSTEM receive FDA 510(k) clearance?

ATLAS MULTI-PURPOSE DSA SYSTEM received FDA 510(k) clearance on 2001-03-12, under 510(k) number K010391.

Who is the listed applicant for ATLAS MULTI-PURPOSE DSA SYSTEM?

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

What is the FDA product code for ATLAS MULTI-PURPOSE DSA SYSTEM?

The FDA product code for ATLAS MULTI-PURPOSE DSA SYSTEM is IZI.

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.

Other records listing Cares Built, 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.

Related Devices (Code: IZI)

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.

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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