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FDA 510(k)

SONOS AIRES 600 (SA-600)

K-Number: K000320 · 2000-05-02

ApplicantKpi Ultrasound, LLC
Decision Date2000-05-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOS AIRES 600 (SA-600) is the device name listed in this FDA 510(k) record. The listed applicant is Kpi Ultrasound, LLC. It received FDA 510(k) clearance on 2000-05-02 under 510(k) number K000320. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOS AIRES 600 (SA-600)?

SONOS AIRES 600 (SA-600) is a medical device that received FDA 510(k) clearance on 2000-05-02. The listed applicant is Kpi Ultrasound, LLC. The 510(k) number is K000320.

When did SONOS AIRES 600 (SA-600) receive FDA 510(k) clearance?

SONOS AIRES 600 (SA-600) received FDA 510(k) clearance on 2000-05-02, under 510(k) number K000320.

Who is the listed applicant for SONOS AIRES 600 (SA-600)?

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

What is the FDA product code for SONOS AIRES 600 (SA-600)?

The FDA product code for SONOS AIRES 600 (SA-600) is IYO.

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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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