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FDA 510(k)

ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202

K-Number: K081154 · 2008-05-23

ApplicantB-K Medical Aps
Decision Date2008-05-23
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 is the device name listed in this FDA 510(k) record. The listed applicant is B-K Medical Aps. It received FDA 510(k) clearance on 2008-05-23 under 510(k) number K081154. 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 FLEX FOCUS, MODEL 1202?

ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 is a medical device that received FDA 510(k) clearance on 2008-05-23. The listed applicant is B-K Medical Aps. The 510(k) number is K081154.

When did ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 receive FDA 510(k) clearance?

ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 received FDA 510(k) clearance on 2008-05-23, under 510(k) number K081154.

Who is the listed applicant for ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202?

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

What is the FDA product code for ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202?

The FDA product code for ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 is IYO.

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Other records listing B-K Medical Aps 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.

K123254ULTRASOUND SCANNER FLEX FOCUSK100919PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202K083667NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337K081323BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818K070077ULTRASOUND SCANNER PROFOCUS, MODEL 2202

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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