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FDA 510(k)

CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM

K-Number: K855229 · 1986-03-25

ApplicantVingmed, Inc.
Decision Date1986-03-25
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vingmed, Inc.. It received FDA 510(k) clearance on 1986-03-25 under 510(k) number K855229. 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 CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM?

CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM is a medical device that received FDA 510(k) clearance on 1986-03-25. The listed applicant is Vingmed, Inc.. The 510(k) number is K855229.

When did CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM receive FDA 510(k) clearance?

CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM received FDA 510(k) clearance on 1986-03-25, under 510(k) number K855229.

Who is the listed applicant for CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM?

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

What is the FDA product code for CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM?

The FDA product code for CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM is DXK.

Related Clinical Trials

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Other records listing Vingmed, 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.

K843933VINGMED DS100 DOPPLER FLOWMETER

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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