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FDA 510(k)

SONALIS, MODEL 2000

K-Number: K043189 · 2005-02-09

Applicant3g Ultrasound, Inc.
Decision Date2005-02-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONALIS, MODEL 2000 is the device name listed in this FDA 510(k) record. The listed applicant is 3g Ultrasound, Inc.. It received FDA 510(k) clearance on 2005-02-09 under 510(k) number K043189. 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 SONALIS, MODEL 2000?

SONALIS, MODEL 2000 is a medical device that received FDA 510(k) clearance on 2005-02-09. The listed applicant is 3g Ultrasound, Inc.. The 510(k) number is K043189.

When did SONALIS, MODEL 2000 receive FDA 510(k) clearance?

SONALIS, MODEL 2000 received FDA 510(k) clearance on 2005-02-09, under 510(k) number K043189.

Who is the listed applicant for SONALIS, MODEL 2000?

The FDA 510(k) record lists 3g Ultrasound, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONALIS, MODEL 2000?

The FDA product code for SONALIS, MODEL 2000 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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