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FDA 510(k)

BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K895645 · 1990-03-06

ApplicantBiosound, Inc.
Decision Date1990-03-06
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND 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 1990-03-06 under 510(k) number K895645. 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 BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM?

BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1990-03-06. The listed applicant is Biosound, Inc.. The 510(k) number is K895645.

When did BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 1990-03-06, under 510(k) number K895645.

Who is the listed applicant for BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND 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 BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM is IYO.

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Other records listing Biosound, Inc. as applicant

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.

K971700BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCERK963936ACCESSPOINT, MED E-MAIL, DICOM READERK963262ARTOSCAN MK963662GALILEO EVOKED POTENTIALREK953716INTRACAVITY TRANSDUCERSK953530DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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