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FDA 510(k)

VINGMED SOUND COLOR FLOW MAPPING SYSTEM

K-Number: K962662 · 1997-01-02

ApplicantDiasonics, Inc.
Decision Date1997-01-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VINGMED SOUND COLOR FLOW MAPPING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diasonics, Inc.. It received FDA 510(k) clearance on 1997-01-02 under 510(k) number K962662. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VINGMED SOUND COLOR FLOW MAPPING SYSTEM?

VINGMED SOUND COLOR FLOW MAPPING SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-02. The listed applicant is Diasonics, Inc.. The 510(k) number is K962662.

When did VINGMED SOUND COLOR FLOW MAPPING SYSTEM receive FDA 510(k) clearance?

VINGMED SOUND COLOR FLOW MAPPING SYSTEM received FDA 510(k) clearance on 1997-01-02, under 510(k) number K962662.

Who is the listed applicant for VINGMED SOUND COLOR FLOW MAPPING SYSTEM?

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

What is the FDA product code for VINGMED SOUND COLOR FLOW MAPPING SYSTEM?

The FDA product code for VINGMED SOUND COLOR FLOW MAPPING SYSTEM is IYO.

Related Clinical Trials

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Other records listing Diasonics, 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.

K924079CFM-800 COLOR FLOW MAPPING SYSTEMK911435CPA/3.5 MHZ PROBEK905200SACA, 3.5 MHZ PROBEK903562CW DOPPLER 2.25 MHZ PROBEK903984CW DOPPLER/4.5 MHZK896637ACCESS(TM), SOFTWARE RELEASE 4.11P

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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