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FDA 510(k)

HR12000 ULTRASOUND SYSTEM

K-Number: K961229 · 1997-05-29

ApplicantInternational Ultrasound Corp.
Decision Date1997-05-29
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HR12000 ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is International Ultrasound Corp.. It received FDA 510(k) clearance on 1997-05-29 under 510(k) number K961229. 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 HR12000 ULTRASOUND SYSTEM?

HR12000 ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1997-05-29. The listed applicant is International Ultrasound Corp.. The 510(k) number is K961229.

When did HR12000 ULTRASOUND SYSTEM receive FDA 510(k) clearance?

HR12000 ULTRASOUND SYSTEM received FDA 510(k) clearance on 1997-05-29, under 510(k) number K961229.

Who is the listed applicant for HR12000 ULTRASOUND SYSTEM?

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

What is the FDA product code for HR12000 ULTRASOUND SYSTEM?

The FDA product code for HR12000 ULTRASOUND SYSTEM 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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