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FDA 510(k)

ULTRASOUND SCANNER MINI FOCUS, MODEL 1402

K-Number: K043554 · 2005-01-14

ApplicantB-K Medical A/S
Decision Date2005-01-14
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 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 2005-01-14 under 510(k) number K043554. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASOUND SCANNER MINI FOCUS, MODEL 1402?

ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 is a medical device that received FDA 510(k) clearance on 2005-01-14. The listed applicant is B-K Medical A/S. The 510(k) number is K043554.

When did ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 receive FDA 510(k) clearance?

ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 received FDA 510(k) clearance on 2005-01-14, under 510(k) number K043554.

Who is the listed applicant for ULTRASOUND SCANNER MINI FOCUS, MODEL 1402?

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 MINI FOCUS, MODEL 1402?

The FDA product code for ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 is IYN.

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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.

K043524ULTRASOUND SCANNER PRO FOCUS, MODEL 2202K024236ULTRASOUND SCANNER, TYPE 2400K023457ULTRASOUND SCANNER, TYPE 1101K011417ULTRASOUND SCANNER, TYPE 2102K003986ULTRASOUND SCANNER TYPE 2102K003041ULTRASOUND SCANNER TYPE 2101

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Related Devices (Code: IYN)

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.

K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCK263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care DiagnosticsK254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)Sonoscape Medical Corp.K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC

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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