FDA 510(k)

4000 AU ULTRASOUND IMAGING SYSTEM

K-Number: K944485 · 1995-05-24

Decision Date1995-05-24

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

4000 AU ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1995-05-24 under 510(k) number K944485. 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 4000 AU ULTRASOUND IMAGING SYSTEM?

4000 AU ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1995-05-24. The listed applicant is Biosound, Inc.. The 510(k) number is K944485.

When did 4000 AU ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

4000 AU ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 1995-05-24, under 510(k) number K944485.

Who is the listed applicant for 4000 AU ULTRASOUND IMAGING SYSTEM?

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

What is the FDA product code for 4000 AU ULTRASOUND IMAGING SYSTEM?

The FDA product code for 4000 AU ULTRASOUND IMAGING SYSTEM is IYO.

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Other records listing Biosound, Inc. as applicant

K971700BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER K963936ACCESSPOINT, MED E-MAIL, DICOM READER K963262ARTOSCAN M K963662GALILEO EVOKED POTENTIALRE K953716INTRACAVITY TRANSDUCERS K953530DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A

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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.