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FDA 510(k)

EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND

K-Number: K862859 · 1987-02-02

ApplicantBiosound, Inc.
Decision Date1987-02-02
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1987-02-02 under 510(k) number K862859. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND?

EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND is a medical device that received FDA 510(k) clearance on 1987-02-02. The listed applicant is Biosound, Inc.. The 510(k) number is K862859.

When did EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND receive FDA 510(k) clearance?

EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND received FDA 510(k) clearance on 1987-02-02, under 510(k) number K862859.

Who is the listed applicant for EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND?

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 EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND?

The FDA product code for EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND is DXK.

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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: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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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