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FDA 510(k)

PORTABLE MEDICAL ULTRASOUND SCANNER

K-Number: K800434 · 1980-04-10

ApplicantBion Ent., Ltd.
Decision Date1980-04-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PORTABLE MEDICAL ULTRASOUND SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Bion Ent., Ltd.. It received FDA 510(k) clearance on 1980-04-10 under 510(k) number K800434. 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 PORTABLE MEDICAL ULTRASOUND SCANNER?

PORTABLE MEDICAL ULTRASOUND SCANNER is a medical device that received FDA 510(k) clearance on 1980-04-10. The listed applicant is Bion Ent., Ltd.. The 510(k) number is K800434.

When did PORTABLE MEDICAL ULTRASOUND SCANNER receive FDA 510(k) clearance?

PORTABLE MEDICAL ULTRASOUND SCANNER received FDA 510(k) clearance on 1980-04-10, under 510(k) number K800434.

Who is the listed applicant for PORTABLE MEDICAL ULTRASOUND SCANNER?

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

What is the FDA product code for PORTABLE MEDICAL ULTRASOUND SCANNER?

The FDA product code for PORTABLE MEDICAL ULTRASOUND SCANNER is IYO.

Related Clinical Trials

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Other records listing Bion Ent., Ltd. 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.

K926066BION MUMPS-G ANTIBODY TEST SYSTEMK901054BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDEK894622VARICELLA ZOSTER VIRUSK894626EPSTEIN-BARR VIRUS-NUCLEAR ANTIGENK894624MUMPS VIRUSK894623RESPIRATORY SYNCYTIAL VIRUS

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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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