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FDA 510(k)

PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065

K-Number: K954884 · 1996-05-28

ApplicantVingmed Sound, Inc.
Decision Date1996-05-28
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065 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 1996-05-28 under 510(k) number K954884. 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 PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065?

PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065 is a medical device that received FDA 510(k) clearance on 1996-05-28. The listed applicant is Vingmed Sound, Inc.. The 510(k) number is K954884.

When did PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065 receive FDA 510(k) clearance?

PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065 received FDA 510(k) clearance on 1996-05-28, under 510(k) number K954884.

Who is the listed applicant for PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065?

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 PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065?

The FDA product code for PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065 is IYO.

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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 FIVEK926108VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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