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FDA 510(k)

DIGITAL DIAGNOSTIC ULTRASOUND DEVICE

K-Number: K810038 · 1981-04-17

ApplicantRohe Scientific Corp.
Decision Date1981-04-17
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL DIAGNOSTIC ULTRASOUND DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Rohe Scientific Corp.. It received FDA 510(k) clearance on 1981-04-17 under 510(k) number K810038. 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 DIGITAL DIAGNOSTIC ULTRASOUND DEVICE?

DIGITAL DIAGNOSTIC ULTRASOUND DEVICE is a medical device that received FDA 510(k) clearance on 1981-04-17. The listed applicant is Rohe Scientific Corp.. The 510(k) number is K810038.

When did DIGITAL DIAGNOSTIC ULTRASOUND DEVICE receive FDA 510(k) clearance?

DIGITAL DIAGNOSTIC ULTRASOUND DEVICE received FDA 510(k) clearance on 1981-04-17, under 510(k) number K810038.

Who is the listed applicant for DIGITAL DIAGNOSTIC ULTRASOUND DEVICE?

The FDA 510(k) record lists Rohe Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL DIAGNOSTIC ULTRASOUND DEVICE?

The FDA product code for DIGITAL DIAGNOSTIC ULTRASOUND DEVICE 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 Rohe Scientific Corp. 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.

K770073PRIMUS INTER PARESECHOCARDIOGRAPHY SYS.

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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