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FDA 510(k)

BIOPSY FIXATION UNIT-TYPE UA 0997

K-Number: K875357 · 1988-07-01

ApplicantBruel & Kjaer Industri A/S
Decision Date1988-07-01
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOPSY FIXATION UNIT-TYPE UA 0997 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 1988-07-01 under 510(k) number K875357. 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 BIOPSY FIXATION UNIT-TYPE UA 0997?

BIOPSY FIXATION UNIT-TYPE UA 0997 is a medical device that received FDA 510(k) clearance on 1988-07-01. The listed applicant is Bruel & Kjaer Industri A/S. The 510(k) number is K875357.

When did BIOPSY FIXATION UNIT-TYPE UA 0997 receive FDA 510(k) clearance?

BIOPSY FIXATION UNIT-TYPE UA 0997 received FDA 510(k) clearance on 1988-07-01, under 510(k) number K875357.

Who is the listed applicant for BIOPSY FIXATION UNIT-TYPE UA 0997?

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 BIOPSY FIXATION UNIT-TYPE UA 0997?

The FDA product code for BIOPSY FIXATION UNIT-TYPE UA 0997 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.

K914945DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIEDK852502AMENDMENT 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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