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FDA 510(k)

ACCESSORY TO GENESIS III (GCFM)

K-Number: K913209 · 1992-05-15

ApplicantBiosound, Inc.
Decision Date1992-05-15
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCESSORY TO GENESIS III (GCFM) is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1992-05-15 under 510(k) number K913209. 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 ACCESSORY TO GENESIS III (GCFM)?

ACCESSORY TO GENESIS III (GCFM) is a medical device that received FDA 510(k) clearance on 1992-05-15. The listed applicant is Biosound, Inc.. The 510(k) number is K913209.

When did ACCESSORY TO GENESIS III (GCFM) receive FDA 510(k) clearance?

ACCESSORY TO GENESIS III (GCFM) received FDA 510(k) clearance on 1992-05-15, under 510(k) number K913209.

Who is the listed applicant for ACCESSORY TO GENESIS III (GCFM)?

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 ACCESSORY TO GENESIS III (GCFM)?

The FDA product code for ACCESSORY TO GENESIS III (GCFM) 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/SK911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.K904832MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYSTHewlett-Packard Co.

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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