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FDA 510(k)

TOMTEC ECHO-SCAN

K-Number: K963807 · 1996-12-18

ApplicantTomtec Imaging Systems, Inc.
Decision Date1996-12-18
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOMTEC ECHO-SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Tomtec Imaging Systems, Inc.. It received FDA 510(k) clearance on 1996-12-18 under 510(k) number K963807. 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 TOMTEC ECHO-SCAN?

TOMTEC ECHO-SCAN is a medical device that received FDA 510(k) clearance on 1996-12-18. The listed applicant is Tomtec Imaging Systems, Inc.. The 510(k) number is K963807.

When did TOMTEC ECHO-SCAN receive FDA 510(k) clearance?

TOMTEC ECHO-SCAN received FDA 510(k) clearance on 1996-12-18, under 510(k) number K963807.

Who is the listed applicant for TOMTEC ECHO-SCAN?

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

What is the FDA product code for TOMTEC ECHO-SCAN?

The FDA product code for TOMTEC ECHO-SCAN is IYO.

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 Tomtec Imaging Systems, 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.

K950279TOMTECP90

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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