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FDA 510(k)

SONOREAL 3D SYSTEM

K-Number: K020068 · 2002-03-04

ApplicantBio Medi Com
Decision Date2002-03-04
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOREAL 3D SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bio Medi Com. It received FDA 510(k) clearance on 2002-03-04 under 510(k) number K020068. 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 SONOREAL 3D SYSTEM?

SONOREAL 3D SYSTEM is a medical device that received FDA 510(k) clearance on 2002-03-04. The listed applicant is Bio Medi Com. The 510(k) number is K020068.

When did SONOREAL 3D SYSTEM receive FDA 510(k) clearance?

SONOREAL 3D SYSTEM received FDA 510(k) clearance on 2002-03-04, under 510(k) number K020068.

Who is the listed applicant for SONOREAL 3D SYSTEM?

The FDA 510(k) record lists Bio Medi Com as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOREAL 3D SYSTEM?

The FDA product code for SONOREAL 3D SYSTEM is IYO.

Related Clinical Trials

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Other records listing Bio Medi Com 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.

K023473SONOREAL 3DK012084SONOREAL 3D

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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