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FDA 510(k)

VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800

K-Number: K926108 · 1993-09-24

ApplicantVingmed Sound, Inc.
Decision Date1993-09-24
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800 is the device name listed in this FDA 510(k) record. The listed applicant is Vingmed Sound, Inc.. It received FDA 510(k) clearance on 1993-09-24 under 510(k) number K926108. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800?

VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800 is a medical device that received FDA 510(k) clearance on 1993-09-24. The listed applicant is Vingmed Sound, Inc.. The 510(k) number is K926108.

When did VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800 receive FDA 510(k) clearance?

VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800 received FDA 510(k) clearance on 1993-09-24, under 510(k) number K926108.

Who is the listed applicant for VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800?

The FDA 510(k) record lists Vingmed Sound, 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, CFM-800?

The FDA product code for VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800 is ITX.

Related Clinical Trials

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.

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Other records listing Vingmed Sound, 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.

K963315VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVEK954884PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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