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FDA 510(k)

COLOR DOPPLER 880

K-Number: K843643 · 1985-01-31

ApplicantIrex Corp.
Decision Date1985-01-31
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COLOR DOPPLER 880 is the device name listed in this FDA 510(k) record. The listed applicant is Irex Corp.. It received FDA 510(k) clearance on 1985-01-31 under 510(k) number K843643. 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 COLOR DOPPLER 880?

COLOR DOPPLER 880 is a medical device that received FDA 510(k) clearance on 1985-01-31. The listed applicant is Irex Corp.. The 510(k) number is K843643.

When did COLOR DOPPLER 880 receive FDA 510(k) clearance?

COLOR DOPPLER 880 received FDA 510(k) clearance on 1985-01-31, under 510(k) number K843643.

Who is the listed applicant for COLOR DOPPLER 880?

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

What is the FDA product code for COLOR DOPPLER 880?

The FDA product code for COLOR DOPPLER 880 is DXK.

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Other records listing Irex Corp. 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.

K844404IREX PS, PORTABLE SCANNER AND 118K842408IREX 730 MECHANICAL SECTOR SCANNERK840139IREX 720 SECTOR SCANNERK827370IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEMK813544IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.K811246DOPPLER ULTRASOUND BLOOD FLOWMETER

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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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