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FDA 510(k)

ULTRASOUND SCANNER, TYPE 1101

K-Number: K023457 · 2002-11-01

ApplicantB-K Medical A/S
Decision Date2002-11-01
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND SCANNER, TYPE 1101 is the device name listed in this FDA 510(k) record. The listed applicant is B-K Medical A/S. It received FDA 510(k) clearance on 2002-11-01 under 510(k) number K023457. 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 ULTRASOUND SCANNER, TYPE 1101?

ULTRASOUND SCANNER, TYPE 1101 is a medical device that received FDA 510(k) clearance on 2002-11-01. The listed applicant is B-K Medical A/S. The 510(k) number is K023457.

When did ULTRASOUND SCANNER, TYPE 1101 receive FDA 510(k) clearance?

ULTRASOUND SCANNER, TYPE 1101 received FDA 510(k) clearance on 2002-11-01, under 510(k) number K023457.

Who is the listed applicant for ULTRASOUND SCANNER, TYPE 1101?

The FDA 510(k) record lists B-K Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASOUND SCANNER, TYPE 1101?

The FDA product code for ULTRASOUND SCANNER, TYPE 1101 is IYO.

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Other records listing B-K Medical 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.

K043554ULTRASOUND SCANNER MINI FOCUS, MODEL 1402K043524ULTRASOUND SCANNER PRO FOCUS, MODEL 2202K024236ULTRASOUND SCANNER, TYPE 2400K011417ULTRASOUND SCANNER, TYPE 2102K003986ULTRASOUND SCANNER TYPE 2102K003041ULTRASOUND SCANNER TYPE 2101

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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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