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FDA 510(k)

DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED

K-Number: K914945 · 1992-06-26

ApplicantBruel & Kjaer Industri A/S
Decision Date1992-06-26
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Bruel & Kjaer Industri A/S. It received FDA 510(k) clearance on 1992-06-26 under 510(k) number K914945. 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 DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED?

DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED is a medical device that received FDA 510(k) clearance on 1992-06-26. The listed applicant is Bruel & Kjaer Industri A/S. The 510(k) number is K914945.

When did DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED receive FDA 510(k) clearance?

DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED received FDA 510(k) clearance on 1992-06-26, under 510(k) number K914945.

Who is the listed applicant for DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED?

The FDA 510(k) record lists Bruel & Kjaer Industri A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED?

The FDA product code for DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED is IYO.

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Other records listing Bruel & Kjaer Industri A/S 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.

K875357BIOPSY FIXATION UNIT-TYPE UA 0997K852502AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849K842090RHINO-LARYNX STROBOSCOPE TYPE 4914

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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