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FDA 510(k)

GENESIS III, (MOD. 7003/7004)

K-Number: K894370 · 1990-01-29

ApplicantBiosound, Inc.
Decision Date1990-01-29
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GENESIS III, (MOD. 7003/7004) is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1990-01-29 under 510(k) number K894370. 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 GENESIS III, (MOD. 7003/7004)?

GENESIS III, (MOD. 7003/7004) is a medical device that received FDA 510(k) clearance on 1990-01-29. The listed applicant is Biosound, Inc.. The 510(k) number is K894370.

When did GENESIS III, (MOD. 7003/7004) receive FDA 510(k) clearance?

GENESIS III, (MOD. 7003/7004) received FDA 510(k) clearance on 1990-01-29, under 510(k) number K894370.

Who is the listed applicant for GENESIS III, (MOD. 7003/7004)?

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 GENESIS III, (MOD. 7003/7004)?

The FDA product code for GENESIS III, (MOD. 7003/7004) 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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