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FDA 510(k)

CARDIOSTREAM SONOAIM

K-Number: K051853 · 2005-08-22

ApplicantCardiostream, LLC
Decision Date2005-08-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIOSTREAM SONOAIM is the device name listed in this FDA 510(k) record. The listed applicant is Cardiostream, LLC. It received FDA 510(k) clearance on 2005-08-22 under 510(k) number K051853. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOSTREAM SONOAIM?

CARDIOSTREAM SONOAIM is a medical device that received FDA 510(k) clearance on 2005-08-22. The listed applicant is Cardiostream, LLC. The 510(k) number is K051853.

When did CARDIOSTREAM SONOAIM receive FDA 510(k) clearance?

CARDIOSTREAM SONOAIM received FDA 510(k) clearance on 2005-08-22, under 510(k) number K051853.

Who is the listed applicant for CARDIOSTREAM SONOAIM?

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

What is the FDA product code for CARDIOSTREAM SONOAIM?

The FDA product code for CARDIOSTREAM SONOAIM is LLZ.

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Related Devices (Code: LLZ)

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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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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